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FDA 510(k)

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK

K-Number: K100727 · 2010-09-14

ApplicantBio-Rad, Diagnostics Grp.
Decision Date2010-09-14
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad, Diagnostics Grp.. It received FDA 510(k) clearance on 2010-09-14 under 510(k) number K100727. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK?

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Bio-Rad, Diagnostics Grp.. The 510(k) number is K100727.

When did LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK receive FDA 510(k) clearance?

LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK received FDA 510(k) clearance on 2010-09-14, under 510(k) number K100727.

Who is the listed applicant for LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK?

The FDA 510(k) record lists Bio-Rad, Diagnostics Grp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK?

The FDA product code for LIQUID ASSAYED MULTIQUAL 1, LIQUID ASSAYED MULTIQUAL 2, LIQUID ASSAYED MULTIQUAL 3, LIQUID ASSAYED MULTIQUAL MINIPAK is JJY.

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Other records listing Bio-Rad, Diagnostics Grp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121794LIQUICHEK URINE CHEMISTRY CONTROLK072835LIQUICHEK MICROALBUMIN CONTROL LEVEL 1, LEVEL 2, CONTROL MINIPAKK072721LYPHOCHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL , ABBOTT IMMUNOSUPPRESSANT MCCK071319I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02K070848LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X

Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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