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FDA 510(k)

GAMMA COUNTER

K-Number: K780344 · 1978-04-12

ApplicantLkb Instruments, Inc.
Decision Date1978-04-12
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Lkb Instruments, Inc.. It received FDA 510(k) clearance on 1978-04-12 under 510(k) number K780344. 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 GAMMA COUNTER?

GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1978-04-12. The listed applicant is Lkb Instruments, Inc.. The 510(k) number is K780344.

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

GAMMA COUNTER received FDA 510(k) clearance on 1978-04-12, under 510(k) number K780344.

Who is the listed applicant for GAMMA COUNTER?

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

What is the FDA product code for GAMMA COUNTER?

The FDA product code for GAMMA COUNTER is JJJ.

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Other records listing Lkb 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.

K8740941205 BETAPLATE LIQUID SCINTILLATION COUNTERK872955DELFIA(TM) FERRITIN KITK871303DELFIA(TM) THYROXINE (T4) KITK871599DELFIA(TM) HIGE KITK871644DELFIA (TM) HTSH KITK864452DELFIA(TM) TRIIODOTHYRONINE (T3) KIT

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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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