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FDA 510(k)

PLATELET AGGREGATION REAGENTS

K-Number: K910286 · 1991-03-19

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1991-03-19
Product CodeGHR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET AGGREGATION REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1991-03-19 under 510(k) number K910286. The device is classified under product code GHR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET AGGREGATION REAGENTS?

PLATELET AGGREGATION REAGENTS is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K910286.

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

PLATELET AGGREGATION REAGENTS received FDA 510(k) clearance on 1991-03-19, under 510(k) number K910286.

Who is the listed applicant for PLATELET AGGREGATION REAGENTS?

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

What is the FDA product code for PLATELET AGGREGATION REAGENTS?

The FDA product code for PLATELET AGGREGATION REAGENTS is GHR.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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Related Devices (Code: GHR)

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.

K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAHelena LaboratoriesK952252ADP REAGENT, MODIFIEDHelena LaboratoriesK922800PLATELET AGGREGATION REAGENTSChrono-Log Corp.K910706COLLAGEN REAGENT CAT. NO. 5368Helena LaboratoriesK910800ADP REAGENTHelena LaboratoriesK910680EPINEPHRINE REAGENT, CAT. NO. 5367Helena Laboratories

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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