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FDA 510(k)

PACE-4-AUTOMATIC RIA GAMMA-COUTER

K-Number: K802578 · 1980-12-18

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1980-12-18
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PACE-4-AUTOMATIC RIA GAMMA-COUTER is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802578. 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 PACE-4-AUTOMATIC RIA GAMMA-COUTER?

PACE-4-AUTOMATIC RIA GAMMA-COUTER is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K802578.

When did PACE-4-AUTOMATIC RIA GAMMA-COUTER receive FDA 510(k) clearance?

PACE-4-AUTOMATIC RIA GAMMA-COUTER received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802578.

Who is the listed applicant for PACE-4-AUTOMATIC RIA GAMMA-COUTER?

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

What is the FDA product code for PACE-4-AUTOMATIC RIA GAMMA-COUTER?

The FDA product code for PACE-4-AUTOMATIC RIA GAMMA-COUTER is JJJ.

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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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