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FDA 510(k)

WELL TYPE GAMMA COUNTER

K-Number: K771613 · 1978-04-10

ApplicantActus, Inc.
Decision Date1978-04-10
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WELL TYPE GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Actus, Inc.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K771613. 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 WELL TYPE GAMMA COUNTER?

WELL TYPE GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is Actus, Inc.. The 510(k) number is K771613.

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

WELL TYPE GAMMA COUNTER received FDA 510(k) clearance on 1978-04-10, under 510(k) number K771613.

Who is the listed applicant for WELL TYPE GAMMA COUNTER?

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

What is the FDA product code for WELL TYPE GAMMA COUNTER?

The FDA product code for WELL TYPE 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 Actus, 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.

K771614AUTO. WELL TYPE GAMMA COUNTERSK771612WELL TYPE GAMMA COUNTERK771301DIGITAL RADIATION DETECTOR

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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