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FDA 510(k)

KEMTEK 103 RIA GAMMA COUNTER

K-Number: K832735 · 1983-09-29

ApplicantKemble Instruments, Inc.
Decision Date1983-09-29
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KEMTEK 103 RIA GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Kemble Instruments, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832735. 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 KEMTEK 103 RIA GAMMA COUNTER?

KEMTEK 103 RIA GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Kemble Instruments, Inc.. The 510(k) number is K832735.

When did KEMTEK 103 RIA GAMMA COUNTER receive FDA 510(k) clearance?

KEMTEK 103 RIA GAMMA COUNTER received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832735.

Who is the listed applicant for KEMTEK 103 RIA GAMMA COUNTER?

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

What is the FDA product code for KEMTEK 103 RIA GAMMA COUNTER?

The FDA product code for KEMTEK 103 RIA GAMMA COUNTER is JJJ.

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Other records listing Kemble Instruments, 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.

K842894KEMBLE 405K832734KEMTEK 400 RIA GAMMA COUNTERK832760RIA SOFTWAREK832736KEMTEK 104 RIA GAMMA COUNTERK830751KEMTEK 102K822293IMMU-COUNT 404

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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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