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FDA 510(k)

ENZYME IMMUNOASSAY FOR DETECTION HORM

K-Number: K841545 · 1984-11-27

ApplicantBtc Diagnostics, Inc.
Decision Date1984-11-27
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME IMMUNOASSAY FOR DETECTION HORM 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 1984-11-27 under 510(k) number K841545. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENZYME IMMUNOASSAY FOR DETECTION HORM?

ENZYME IMMUNOASSAY FOR DETECTION HORM is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is Btc Diagnostics, Inc.. The 510(k) number is K841545.

When did ENZYME IMMUNOASSAY FOR DETECTION HORM receive FDA 510(k) clearance?

ENZYME IMMUNOASSAY FOR DETECTION HORM received FDA 510(k) clearance on 1984-11-27, under 510(k) number K841545.

Who is the listed applicant for ENZYME IMMUNOASSAY FOR DETECTION HORM?

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 ENZYME IMMUNOASSAY FOR DETECTION HORM?

The FDA product code for ENZYME IMMUNOASSAY FOR DETECTION HORM is CEP.

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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.

K832905QUALITATIVE ENZYME IMMUNOASSAY-DETECTK833710BTC URINE LH ASSAYK831604HCG ACCU-STICKK831125BTC URINE LCG ASSAY

Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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