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FDA 510(k)

ASSERACHROM PF4 KIT

K-Number: K862774 · 1986-09-04

ApplicantAmerican Bioproducts Co.
Decision Date1986-09-04
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASSERACHROM PF4 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 1986-09-04 under 510(k) number K862774. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSERACHROM PF4 KIT?

ASSERACHROM PF4 KIT is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is American Bioproducts Co.. The 510(k) number is K862774.

When did ASSERACHROM PF4 KIT receive FDA 510(k) clearance?

ASSERACHROM PF4 KIT received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862774.

Who is the listed applicant for ASSERACHROM PF4 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 PF4 KIT?

The FDA product code for ASSERACHROM PF4 KIT is LCO.

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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: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory COK153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory COK071781PF4 IGGGenetic Testing Institute

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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