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FDA 510(k)

BTC URINE LH ASSAY

K-Number: K833710 · 1984-01-30

ApplicantBtc Diagnostics, Inc.
Decision Date1984-01-30
Product CodeCED
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BTC URINE LH 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 1984-01-30 under 510(k) number K833710. The device is classified under product code CED. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTC URINE LH ASSAY?

BTC URINE LH ASSAY is a medical device that received FDA 510(k) clearance on 1984-01-30. The listed applicant is Btc Diagnostics, Inc.. The 510(k) number is K833710.

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

BTC URINE LH ASSAY received FDA 510(k) clearance on 1984-01-30, under 510(k) number K833710.

Who is the listed applicant for BTC URINE LH 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 LH ASSAY?

The FDA product code for BTC URINE LH ASSAY is CED.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-DETECTK831604HCG ACCU-STICKK831125BTC URINE LCG ASSAY

Related Devices (Code: CED)

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.

K894288PHOSPHORUS TEST ITEM NUMBER 65416Em Diagnostic Systems, Inc.K840151EKTACHEM CLINICAL CHEM. SLIDESEastman Kodak CompanyK820832PHOSPHORUS ILAmerican Monitor Corp.K812670SANDARE FAST 340 PHOSPHORUS PROCEDURESandare Chemical Co., Inc.K811864SIGMA PROCEDURE 265-UVSigma Chemical Co.K811222INORGANIC PHOSPHORUS REAGENTSConnecticut Diagnostics, Ltd.

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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