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FDA 510(k)

CORNING 4000 MULTI-WELL GAMMA COUNTER

K-Number: K834508 · 1984-03-16

ApplicantCorning Medical & Scientific
Decision Date1984-03-16
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CORNING 4000 MULTI-WELL GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1984-03-16 under 510(k) number K834508. 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 CORNING 4000 MULTI-WELL GAMMA COUNTER?

CORNING 4000 MULTI-WELL GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1984-03-16. The listed applicant is Corning Medical & Scientific. The 510(k) number is K834508.

When did CORNING 4000 MULTI-WELL GAMMA COUNTER receive FDA 510(k) clearance?

CORNING 4000 MULTI-WELL GAMMA COUNTER received FDA 510(k) clearance on 1984-03-16, under 510(k) number K834508.

Who is the listed applicant for CORNING 4000 MULTI-WELL GAMMA COUNTER?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORNING 4000 MULTI-WELL GAMMA COUNTER?

The FDA product code for CORNING 4000 MULTI-WELL GAMMA COUNTER is JJJ.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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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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