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FDA 510(k)

COUNTER, RADIOASSAY, AUTO., MICROMEDIC

K-Number: K780383 · 1978-03-22

ApplicantMicromedic Systems
Decision Date1978-03-22
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COUNTER, RADIOASSAY, AUTO., MICROMEDIC is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1978-03-22 under 510(k) number K780383. 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 COUNTER, RADIOASSAY, AUTO., MICROMEDIC?

COUNTER, RADIOASSAY, AUTO., MICROMEDIC is a medical device that received FDA 510(k) clearance on 1978-03-22. The listed applicant is Micromedic Systems. The 510(k) number is K780383.

When did COUNTER, RADIOASSAY, AUTO., MICROMEDIC receive FDA 510(k) clearance?

COUNTER, RADIOASSAY, AUTO., MICROMEDIC received FDA 510(k) clearance on 1978-03-22, under 510(k) number K780383.

Who is the listed applicant for COUNTER, RADIOASSAY, AUTO., MICROMEDIC?

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 COUNTER, RADIOASSAY, AUTO., MICROMEDIC?

The FDA product code for COUNTER, RADIOASSAY, AUTO., MICROMEDIC 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 KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871008MICROMEDIC NEONATAL T4 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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