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FDA 510(k)

PAT PLATELET AGGREGATION TEST

K-Number: K881829 · 1988-07-01

ApplicantStreck Laboratories, Inc.
Decision Date1988-07-01
Product CodeJBX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PAT PLATELET AGGREGATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Streck Laboratories, Inc.. It received FDA 510(k) clearance on 1988-07-01 under 510(k) number K881829. The device is classified under product code JBX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAT PLATELET AGGREGATION TEST?

PAT PLATELET AGGREGATION TEST is a medical device that received FDA 510(k) clearance on 1988-07-01. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K881829.

When did PAT PLATELET AGGREGATION TEST receive FDA 510(k) clearance?

PAT PLATELET AGGREGATION TEST received FDA 510(k) clearance on 1988-07-01, under 510(k) number K881829.

Who is the listed applicant for PAT PLATELET AGGREGATION TEST?

The FDA 510(k) record lists Streck Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PAT PLATELET AGGREGATION TEST?

The FDA product code for PAT PLATELET AGGREGATION TEST is JBX.

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Other records listing Streck Laboratories, Inc. 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.

K042587RETIC-CHEX FOR CELL-DYNK040107CYTO-CHEX BCTK040025A1C-CELLULARK023656SICKLE-CHEX SOLUBILITY KITK021922MODIFICATION TO PARA 5XK020469CAL-CHEX CD PLUS

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Related Devices (Code: JBX)

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.

K932566AGGRO/LINK CONTROL SOFTWAREChrono-Log Corp.K912774ARACHIDONIC ACIDHelena LaboratoriesK862775ASSERACHROM B-TG KITAmerican Bioproducts Co.K851025AGGRO/LINK COMPUTER INTERFACEChrono-Log Corp.K850592PLATELET AGGREGATION REAGENTChrono-Log Corp.K832929RISTOCETIN PLATELET AGGREGA-REAGENT TESTSigma Chemical Co.

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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