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FDA 510(k)

ISO-DATA 500 SERIES GAMMA COUNTER

K-Number: K872430 · 1987-08-21

ApplicantIso-Data, Inc.
Decision Date1987-08-21
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISO-DATA 500 SERIES GAMMA COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Iso-Data, Inc.. It received FDA 510(k) clearance on 1987-08-21 under 510(k) number K872430. 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 ISO-DATA 500 SERIES GAMMA COUNTER?

ISO-DATA 500 SERIES GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1987-08-21. The listed applicant is Iso-Data, Inc.. The 510(k) number is K872430.

When did ISO-DATA 500 SERIES GAMMA COUNTER receive FDA 510(k) clearance?

ISO-DATA 500 SERIES GAMMA COUNTER received FDA 510(k) clearance on 1987-08-21, under 510(k) number K872430.

Who is the listed applicant for ISO-DATA 500 SERIES GAMMA COUNTER?

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

What is the FDA product code for ISO-DATA 500 SERIES GAMMA COUNTER?

The FDA product code for ISO-DATA 500 SERIES GAMMA COUNTER is JJJ.

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Other records listing Iso-Data, 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.

K872429ISO-DATA 100 SERIES GAMMA COUNTERK843434ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.K843365ISO-DATA IMMUNOASSAY NETWORK SYSTEMK810631DPM CALCULATORK780813IDI GDR DATA REDUCTION SYSTEMK780790IDI 200 GAMMA COUNTER

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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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