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FDA 510(k)

LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL

K-Number: K883247 · 1988-09-13

ApplicantQuantimetrix Medical Industries
Decision Date1988-09-13
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL 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 1988-09-13 under 510(k) number K883247. 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 LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL?

LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Quantimetrix Medical Industries. The 510(k) number is K883247.

When did LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL receive FDA 510(k) clearance?

LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883247.

Who is the listed applicant for LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL?

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 LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL?

The FDA product code for LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL 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 ISOENZYK874302QUANTIMETRIX TOTAL CREATINE KINASE CONTROLK874890QUANTIMETRIX URINE DIPSTICK CONTROLK873011QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2K873467QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

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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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