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FDA 510(k)

MICROSTAT GAMMA COUNTER

K-Number: K842902 · 1984-08-09

ApplicantMicromedic Systems
Decision Date1984-08-09
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROSTAT GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1984-08-09 under 510(k) number K842902. The device is classified under product code JJJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSTAT GAMMA COUNTER?

MICROSTAT GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1984-08-09. The listed applicant is Micromedic Systems. The 510(k) number is K842902.

When did MICROSTAT GAMMA COUNTER receive FDA 510(k) clearance?

MICROSTAT GAMMA COUNTER received FDA 510(k) clearance on 1984-08-09, under 510(k) number K842902.

Who is the listed applicant for MICROSTAT GAMMA COUNTER?

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

What is the FDA product code for MICROSTAT GAMMA COUNTER?

The FDA product code for MICROSTAT GAMMA COUNTER is JJJ.

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Other records listing Micromedic Systems 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.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK871008MICROMEDIC NEONATAL T4 KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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Related Devices (Code: JJJ)

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.

K962762SEQUENTIAL SAMPLE MULTI-PHOTON DETECTORBiotraces, Inc.K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERCapintec, Inc.K920559ABBOTT VERTEX ANALYZERAbbott LaboratoriesK900087GENESYS 6000 GAMMA COUNTERLaboratory Technologies, Inc.K896202MATRIX(TM)-96Canberra Industries, Inc.K894902SOURCEREROakfield Instruments, 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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