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FDA 510(k)

GENESYS GAMMA COUNTER

K-Number: K851689 · 1985-08-07

ApplicantLaboratory Technologies, Inc.
Decision Date1985-08-07
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENESYS GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Technologies, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K851689. 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 GENESYS GAMMA COUNTER?

GENESYS GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Laboratory Technologies, Inc.. The 510(k) number is K851689.

When did GENESYS GAMMA COUNTER receive FDA 510(k) clearance?

GENESYS GAMMA COUNTER received FDA 510(k) clearance on 1985-08-07, under 510(k) number K851689.

Who is the listed applicant for GENESYS GAMMA COUNTER?

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

What is the FDA product code for GENESYS GAMMA COUNTER?

The FDA product code for GENESYS GAMMA COUNTER is JJJ.

Related Clinical Trials

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.

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Other records listing Laboratory Technologies, 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.

K921536ACCULYTE CHEMILUMINESCENCE ANALYZERK900087GENESYS 6000 GAMMA COUNTERK882194GEMINII GAMMA COUNTER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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