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FDA 510(k)

QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID

K-Number: K861448 · 1986-04-28

ApplicantQuantimetrix Medical Industries
Decision Date1986-04-28
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Medical Industries. It received FDA 510(k) clearance on 1986-04-28 under 510(k) number K861448. 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 QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID?

QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K861448.

When did QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID receive FDA 510(k) clearance?

QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID received FDA 510(k) clearance on 1986-04-28, under 510(k) number K861448.

Who is the listed applicant for QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID?

The FDA 510(k) record lists Quantimetrix Medical Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID?

The FDA product code for QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID is JJY.

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Other records listing Quantimetrix Medical Industries 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.

K895778QUANTIMETRIX BILIRUBIN CALIBRATORSK883395ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZYK883247LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROLK874302QUANTIMETRIX TOTAL CREATINE KINASE CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873011QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2

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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

View on FDA Database →

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

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