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FDA 510(k)

NUCLEAR ENTERPRISES 1600/GAMMA COUNTER

K-Number: K801264 · 1980-06-26

ApplicantNuclear Ent. , Ltd.
Decision Date1980-06-26
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NUCLEAR ENTERPRISES 1600/GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Ent. , Ltd.. It received FDA 510(k) clearance on 1980-06-26 under 510(k) number K801264. 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 NUCLEAR ENTERPRISES 1600/GAMMA COUNTER?

NUCLEAR ENTERPRISES 1600/GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1980-06-26. The listed applicant is Nuclear Ent. , Ltd.. The 510(k) number is K801264.

When did NUCLEAR ENTERPRISES 1600/GAMMA COUNTER receive FDA 510(k) clearance?

NUCLEAR ENTERPRISES 1600/GAMMA COUNTER received FDA 510(k) clearance on 1980-06-26, under 510(k) number K801264.

Who is the listed applicant for NUCLEAR ENTERPRISES 1600/GAMMA COUNTER?

The FDA 510(k) record lists Nuclear Ent. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUCLEAR ENTERPRISES 1600/GAMMA COUNTER?

The FDA product code for NUCLEAR ENTERPRISES 1600/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 Nuclear Ent. , Ltd. 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.

K801263NUCLEAR ENTERPRISES 1612 MULTI-WELLK790961LIQUID SCINTILLATION 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

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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