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FDA 510(k)

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT

K-Number: K870573 · 1987-04-22

ApplicantCambridge Medical Technology
Decision Date1987-04-22
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Technology. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K870573. 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 T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT?

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Cambridge Medical Technology. The 510(k) number is K870573.

When did T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1987-04-22, under 510(k) number K870573.

Who is the listed applicant for T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Cambridge Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA product code for T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT is CDX.

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Other records listing Cambridge Medical Technology 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.

K890837RIA-GNOST INSULINK890697RIA-GNOST FERRITINK890836RIA-GNOST PROGESTERONEK873737NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAYK862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOLK860130TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT

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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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