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FDA 510(k)

MICRO-ELISA HLH TEST KIT MONOCLONAL

K-Number: K860333 · 1986-04-21

ApplicantBioclinical Systems, Inc.
Decision Date1986-04-21
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO-ELISA HLH TEST KIT MONOCLONAL is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1986-04-21 under 510(k) number K860333. 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 MICRO-ELISA HLH TEST KIT MONOCLONAL?

MICRO-ELISA HLH TEST KIT MONOCLONAL is a medical device that received FDA 510(k) clearance on 1986-04-21. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K860333.

When did MICRO-ELISA HLH TEST KIT MONOCLONAL receive FDA 510(k) clearance?

MICRO-ELISA HLH TEST KIT MONOCLONAL received FDA 510(k) clearance on 1986-04-21, under 510(k) number K860333.

Who is the listed applicant for MICRO-ELISA HLH TEST KIT MONOCLONAL?

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

What is the FDA product code for MICRO-ELISA HLH TEST KIT MONOCLONAL?

The FDA product code for MICRO-ELISA HLH TEST KIT MONOCLONAL is CEP.

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Other records listing Bioclinical Systems, 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.

K950196CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIAK945911CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARSK933122MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGARK933121MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGARK873086ROUND 1K860334VISI-CHECK HLH TEST MONOCLONAL

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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

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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