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FDA 510(k)

PLATELET KIT

K-Number: K772105 · 1977-11-30

ApplicantStreck Laboratories, Inc.
Decision Date1977-11-30
Product CodeGLG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET KIT 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 1977-11-30 under 510(k) number K772105. The device is classified under product code GLG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET KIT?

PLATELET KIT is a medical device that received FDA 510(k) clearance on 1977-11-30. The listed applicant is Streck Laboratories, Inc.. The 510(k) number is K772105.

When did PLATELET KIT receive FDA 510(k) clearance?

PLATELET KIT received FDA 510(k) clearance on 1977-11-30, under 510(k) number K772105.

Who is the listed applicant for PLATELET KIT?

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 PLATELET KIT?

The FDA product code for PLATELET KIT is GLG.

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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: GLG)

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.

K842921REES & ECKER DILUTION FLUIDE K Ind., Inc.K811084LABTRONIX PLATELET COUNTER(L/O/C.)Labtronix Corp.

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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