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FDA 510(k)

LIPID CONTROL SERUM

K-Number: K872376 · 1987-08-05

ApplicantBiological Industries
Decision Date1987-08-05
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPID CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Biological Industries. It received FDA 510(k) clearance on 1987-08-05 under 510(k) number K872376. 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 LIPID CONTROL SERUM?

LIPID CONTROL SERUM is a medical device that received FDA 510(k) clearance on 1987-08-05. The listed applicant is Biological Industries. The 510(k) number is K872376.

When did LIPID CONTROL SERUM receive FDA 510(k) clearance?

LIPID CONTROL SERUM received FDA 510(k) clearance on 1987-08-05, under 510(k) number K872376.

Who is the listed applicant for LIPID CONTROL SERUM?

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

What is the FDA product code for LIPID CONTROL SERUM?

The FDA product code for LIPID CONTROL SERUM 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 Biological 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.

K871788LIQUID TDM CONTROLS

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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