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FDA 510(k)

KEMTEK 102

K-Number: K830751 · 1983-04-06

ApplicantKemble Instruments, Inc.
Decision Date1983-04-06
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KEMTEK 102 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 1983-04-06 under 510(k) number K830751. 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 102?

KEMTEK 102 is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Kemble Instruments, Inc.. The 510(k) number is K830751.

When did KEMTEK 102 receive FDA 510(k) clearance?

KEMTEK 102 received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830751.

Who is the listed applicant for KEMTEK 102?

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 102?

The FDA product code for KEMTEK 102 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 SOFTWAREK832735KEMTEK 103 RIA GAMMA COUNTERK832736KEMTEK 104 RIA GAMMA COUNTERK822293IMMU-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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