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FDA 510(k)

IMMU-COUNT 404

K-Number: K822293 · 1982-08-24

ApplicantKemble Instruments, Inc.
Decision Date1982-08-24
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMU-COUNT 404 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 1982-08-24 under 510(k) number K822293. 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 IMMU-COUNT 404?

IMMU-COUNT 404 is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Kemble Instruments, Inc.. The 510(k) number is K822293.

When did IMMU-COUNT 404 receive FDA 510(k) clearance?

IMMU-COUNT 404 received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822293.

Who is the listed applicant for IMMU-COUNT 404?

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 IMMU-COUNT 404?

The FDA product code for IMMU-COUNT 404 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 COUNTERK830751KEMTEK 102

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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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