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FDA 510(k)

BTC URINE LCG ASSAY

K-Number: K831125 · 1983-05-05

ApplicantBtc Diagnostics, Inc.
Decision Date1983-05-05
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BTC URINE LCG ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Btc Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-05-05 under 510(k) number K831125. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTC URINE LCG ASSAY?

BTC URINE LCG ASSAY is a medical device that received FDA 510(k) clearance on 1983-05-05. The listed applicant is Btc Diagnostics, Inc.. The 510(k) number is K831125.

When did BTC URINE LCG ASSAY receive FDA 510(k) clearance?

BTC URINE LCG ASSAY received FDA 510(k) clearance on 1983-05-05, under 510(k) number K831125.

Who is the listed applicant for BTC URINE LCG ASSAY?

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

What is the FDA product code for BTC URINE LCG ASSAY?

The FDA product code for BTC URINE LCG ASSAY is JHJ.

Related Clinical Trials

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.

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Other records listing Btc 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.

K841545ENZYME IMMUNOASSAY FOR DETECTION HORMK832905QUALITATIVE ENZYME IMMUNOASSAY-DETECTK833710BTC URINE LH ASSAYK831604HCG ACCU-STICK

Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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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