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FDA 510(k)

IMMULITE(TM) T-UPTAKE

K-Number: K910677 · 1991-04-29

ApplicantCirrus Diagnostics, Inc.
Decision Date1991-04-29
Product CodeCEE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE(TM) T-UPTAKE is the device name listed in this FDA 510(k) record. The listed applicant is Cirrus Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-04-29 under 510(k) number K910677. 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 IMMULITE(TM) T-UPTAKE?

IMMULITE(TM) T-UPTAKE is a medical device that received FDA 510(k) clearance on 1991-04-29. The listed applicant is Cirrus Diagnostics, Inc.. The 510(k) number is K910677.

When did IMMULITE(TM) T-UPTAKE receive FDA 510(k) clearance?

IMMULITE(TM) T-UPTAKE received FDA 510(k) clearance on 1991-04-29, under 510(k) number K910677.

Who is the listed applicant for IMMULITE(TM) T-UPTAKE?

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

What is the FDA product code for IMMULITE(TM) T-UPTAKE?

The FDA product code for IMMULITE(TM) T-UPTAKE is CEE.

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Other records listing Cirrus 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.

K921704IMMULITE(R) FSHK920411IMMULITE HLHK914833IMMULITE DIGOXINK911796IMMULITE(TM) HCGK910261IMMULITE(TM) TOTAL T4K905648CRP LIPID REAGENT TEST PACK

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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.K905777MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KITImmunotech Corp.K900240DELFIA TBG KITPharmacia, Inc.K896991ENZYMUN TEST(R) TBKBoehringer Mannheim Corp.K893469AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KITAmersham 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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