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FDA 510(k)

NML 5000 AUTO. GAMMA SCINT. COUNTER

K-Number: K800388 · 1980-03-12

ApplicantNuclear Medical Laboratories, Inc.
Decision Date1980-03-12
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NML 5000 AUTO. GAMMA SCINT. COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Medical Laboratories, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800388. 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 NML 5000 AUTO. GAMMA SCINT. COUNTER?

NML 5000 AUTO. GAMMA SCINT. COUNTER is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Nuclear Medical Laboratories, Inc.. The 510(k) number is K800388.

When did NML 5000 AUTO. GAMMA SCINT. COUNTER receive FDA 510(k) clearance?

NML 5000 AUTO. GAMMA SCINT. COUNTER received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800388.

Who is the listed applicant for NML 5000 AUTO. GAMMA SCINT. COUNTER?

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

What is the FDA product code for NML 5000 AUTO. GAMMA SCINT. COUNTER?

The FDA product code for NML 5000 AUTO. GAMMA SCINT. COUNTER is JJJ.

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Other records listing Nuclear Medical Laboratories, 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.

K852438NML TSH IRMAK844583TSH-STATK840466NML CORTISOL RIAK840589TRI-TUBE RIAK832892MODIFIED CHORIO-SHUREK832002NML-5010/5020 MULTI-DETECTOR SYSTEM

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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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