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FDA 510(k)

RIA PHASE T4

K-Number: K800203 · 1980-03-19

ApplicantBoehringer Mannheim Corp.
Decision Date1980-03-19
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA PHASE T4 is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800203. 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 RIA PHASE T4?

RIA PHASE T4 is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K800203.

When did RIA PHASE T4 receive FDA 510(k) clearance?

RIA PHASE T4 received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800203.

Who is the listed applicant for RIA PHASE T4?

The FDA 510(k) record lists Boehringer Mannheim Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIA PHASE T4?

The FDA product code for RIA PHASE T4 is CDX.

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Other records listing Boehringer Mannheim Corp. 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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