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FDA 510(k)

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)

K-Number: K873625 · 1987-10-20

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1987-10-20
Product CodeJLM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-10-20 under 510(k) number K873625. The device is classified under product code JLM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)?

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) is a medical device that received FDA 510(k) clearance on 1987-10-20. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K873625.

When did CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) receive FDA 510(k) clearance?

CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) received FDA 510(k) clearance on 1987-10-20, under 510(k) number K873625.

Who is the listed applicant for CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)?

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

What is the FDA product code for CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)?

The FDA product code for CHEMELIA ENZYME IMMUNOASSAY FOR (TSH) is JLM.

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Other records listing Boots-Celltech 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.

K871877IDEIA HERPES SIMPLEX VIRUS TESTK880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIK872843OVEIA (TM) DUAL ANALYTE

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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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