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FDA 510(k)

HYDRAGAMMA 16

K-Number: K800601 · 1980-04-10

ApplicantInnotron of Oregon, Inc.
Decision Date1980-04-10
Product CodeJJJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDRAGAMMA 16 is the device name listed in this FDA 510(k) record. The listed applicant is Innotron of Oregon, Inc.. It received FDA 510(k) clearance on 1980-04-10 under 510(k) number K800601. 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 HYDRAGAMMA 16?

HYDRAGAMMA 16 is a medical device that received FDA 510(k) clearance on 1980-04-10. The listed applicant is Innotron of Oregon, Inc.. The 510(k) number is K800601.

When did HYDRAGAMMA 16 receive FDA 510(k) clearance?

HYDRAGAMMA 16 received FDA 510(k) clearance on 1980-04-10, under 510(k) number K800601.

Who is the listed applicant for HYDRAGAMMA 16?

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

What is the FDA product code for HYDRAGAMMA 16?

The FDA product code for HYDRAGAMMA 16 is JJJ.

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Other records listing Innotron of Oregon, Inc. as applicant

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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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