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FDA 510(k)

ASSERACHROM PROTEIN C KIT

K-Number: K854016 · 1986-01-03

ApplicantAmerican Bioproducts Co.
Decision Date1986-01-03
Product CodeJLA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASSERACHROM PROTEIN C KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K854016. The device is classified under product code JLA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSERACHROM PROTEIN C KIT?

ASSERACHROM PROTEIN C KIT is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is American Bioproducts Co.. The 510(k) number is K854016.

When did ASSERACHROM PROTEIN C KIT receive FDA 510(k) clearance?

ASSERACHROM PROTEIN C KIT received FDA 510(k) clearance on 1986-01-03, under 510(k) number K854016.

Who is the listed applicant for ASSERACHROM PROTEIN C KIT?

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

What is the FDA product code for ASSERACHROM PROTEIN C KIT?

The FDA product code for ASSERACHROM PROTEIN C KIT is JLA.

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Other records listing American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KIT

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Related Devices (Code: JLA)

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.

K852767ERYTHOCYTE CREATINEPanmed, Inc.

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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