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FDA 510(k)

FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT

K-Number: K884201 · 1988-12-14

ApplicantCyberfluor, Inc.
Decision Date1988-12-14
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cyberfluor, Inc.. It received FDA 510(k) clearance on 1988-12-14 under 510(k) number K884201. The device is classified under product code CEE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT?

FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1988-12-14. The listed applicant is Cyberfluor, Inc.. The 510(k) number is K884201.

When did FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT receive FDA 510(k) clearance?

FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT received FDA 510(k) clearance on 1988-12-14, under 510(k) number K884201.

Who is the listed applicant for FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT?

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

What is the FDA product code for FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT?

The FDA product code for FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT is CEE.

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Other records listing Cyberfluor, 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.

K923410FIAGEN PROGESTERONEK905656FLAGEN TRIIODOTHYRONINE (T3) ASSAYK904539FLAGEN TM FREE T4K900621FIAGEN(TM) HLH.SK895186FIAGEN T3 UPTAKE CATALOGUE #101-402K895396CYBERFLUOR FIAGEN TSH

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Related Devices (Code: CEE)

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.

K952284AMERLITE TBG ASSAYJohnson & Johnson Clinical Diagnostics, Inc.K930010ACCESS THYROID UPTAKE ASSAYBio-Rad Laboratories, Inc.K910677IMMULITE(TM) T-UPTAKECirrus Diagnostics, Inc.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer Mannheim 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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