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FDA 510(k)

THROMBOPLASTIN

K-Number: K884855 · 1989-01-30

ApplicantPrecision Biologicals, Inc.
Decision Date1989-01-30
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOPLASTIN is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologicals, Inc.. It received FDA 510(k) clearance on 1989-01-30 under 510(k) number K884855. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOPLASTIN?

THROMBOPLASTIN is a medical device that received FDA 510(k) clearance on 1989-01-30. The listed applicant is Precision Biologicals, Inc.. The 510(k) number is K884855.

When did THROMBOPLASTIN receive FDA 510(k) clearance?

THROMBOPLASTIN received FDA 510(k) clearance on 1989-01-30, under 510(k) number K884855.

Who is the listed applicant for THROMBOPLASTIN?

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

What is the FDA product code for THROMBOPLASTIN?

The FDA product code for THROMBOPLASTIN is GJS.

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Other records listing Precision Biologicals, 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.

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Related Devices (Code: GJS)

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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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