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FDA 510(k)

THYRODOT-4 ANTISERA LYOPHOLIZED

K-Number: K772064 · 1977-11-14

ApplicantMedcom Diagnostics, Inc.
Decision Date1977-11-14
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THYRODOT-4 ANTISERA LYOPHOLIZED is the device name listed in this FDA 510(k) record. The listed applicant is Medcom Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-11-14 under 510(k) number K772064. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THYRODOT-4 ANTISERA LYOPHOLIZED?

THYRODOT-4 ANTISERA LYOPHOLIZED is a medical device that received FDA 510(k) clearance on 1977-11-14. The listed applicant is Medcom Diagnostics, Inc.. The 510(k) number is K772064.

When did THYRODOT-4 ANTISERA LYOPHOLIZED receive FDA 510(k) clearance?

THYRODOT-4 ANTISERA LYOPHOLIZED received FDA 510(k) clearance on 1977-11-14, under 510(k) number K772064.

Who is the listed applicant for THYRODOT-4 ANTISERA LYOPHOLIZED?

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

What is the FDA product code for THYRODOT-4 ANTISERA LYOPHOLIZED?

The FDA product code for THYRODOT-4 ANTISERA LYOPHOLIZED is CDX.

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Other records listing Medcom Diagnostics, 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.

K771377THYRODOT-4, THYRODOT-SH

Related Devices (Code: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

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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