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FDA 510(k)

GAMMA STIK 125I T3 UPTAKE KIT

K-Number: K780492 · 1978-04-28

ApplicantAlpha Gamma Laboratory
Decision Date1978-04-28
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA STIK 125I T3 UPTAKE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Gamma Laboratory. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K780492. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMA STIK 125I T3 UPTAKE KIT?

GAMMA STIK 125I T3 UPTAKE KIT is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Alpha Gamma Laboratory. The 510(k) number is K780492.

When did GAMMA STIK 125I T3 UPTAKE KIT receive FDA 510(k) clearance?

GAMMA STIK 125I T3 UPTAKE KIT received FDA 510(k) clearance on 1978-04-28, under 510(k) number K780492.

Who is the listed applicant for GAMMA STIK 125I T3 UPTAKE KIT?

The FDA 510(k) record lists Alpha Gamma Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMA STIK 125I T3 UPTAKE KIT?

The FDA product code for GAMMA STIK 125I T3 UPTAKE KIT is CDP.

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Other records listing Alpha Gamma Laboratory 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.

K810011GAMMA STICK 125-1 TOBRAMYCIN RIA KITK800537GAMMA STICK GENTAMICIN RIA KITK800538GAMMA STICK CORTISOL RIA KIT/STICK KIT

Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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