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FDA 510(k)

A.QC CHEMISTRY CONTROL LEVEL 2

K-Number: K883012 · 1988-09-09

ApplicantArden Medical Systems, Inc.
Decision Date1988-09-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A.QC CHEMISTRY CONTROL LEVEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is Arden Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-09-09 under 510(k) number K883012. 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 A.QC CHEMISTRY CONTROL LEVEL 2?

A.QC CHEMISTRY CONTROL LEVEL 2 is a medical device that received FDA 510(k) clearance on 1988-09-09. The listed applicant is Arden Medical Systems, Inc.. The 510(k) number is K883012.

When did A.QC CHEMISTRY CONTROL LEVEL 2 receive FDA 510(k) clearance?

A.QC CHEMISTRY CONTROL LEVEL 2 received FDA 510(k) clearance on 1988-09-09, under 510(k) number K883012.

Who is the listed applicant for A.QC CHEMISTRY CONTROL LEVEL 2?

The FDA 510(k) record lists Arden Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.QC CHEMISTRY CONTROL LEVEL 2?

The FDA product code for A.QC CHEMISTRY CONTROL LEVEL 2 is JJY.

Related Clinical Trials

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.

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Other records listing Arden Medical Systems, Inc. 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.

K873611A-QC CLINICAL CHEMISTRY CONTROLK870860CHEMPRO 1000(TM)

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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