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FDA 510(k)

IDI 200 GAMMA COUNTER

K-Number: K780790 · 1978-06-22

ApplicantIso-Data, Inc.
Decision Date1978-06-22
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IDI 200 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 1978-06-22 under 510(k) number K780790. 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 IDI 200 GAMMA COUNTER?

IDI 200 GAMMA COUNTER is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Iso-Data, Inc.. The 510(k) number is K780790.

When did IDI 200 GAMMA COUNTER receive FDA 510(k) clearance?

IDI 200 GAMMA COUNTER received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780790.

Who is the listed applicant for IDI 200 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 IDI 200 GAMMA COUNTER?

The FDA product code for IDI 200 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 COUNTERK872430ISO-DATA 500 SERIES GAMMA COUNTERK843434ISO-DATA CENTRIFUGES 1-A, 101, 2D, ETC.K843365ISO-DATA IMMUNOASSAY NETWORK SYSTEMK810631DPM CALCULATORK780813IDI GDR DATA REDUCTION 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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