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FDA 510(k)

ISOENZYME SERUM CONTROL

K-Number: K780147 · 1978-02-23

ApplicantCorning Medical & Scientific
Decision Date1978-02-23
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOENZYME SERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Corning Medical & Scientific. It received FDA 510(k) clearance on 1978-02-23 under 510(k) number K780147. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOENZYME SERUM CONTROL?

ISOENZYME SERUM CONTROL is a medical device that received FDA 510(k) clearance on 1978-02-23. The listed applicant is Corning Medical & Scientific. The 510(k) number is K780147.

When did ISOENZYME SERUM CONTROL receive FDA 510(k) clearance?

ISOENZYME SERUM CONTROL received FDA 510(k) clearance on 1978-02-23, under 510(k) number K780147.

Who is the listed applicant for ISOENZYME SERUM CONTROL?

The FDA 510(k) record lists Corning Medical & Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOENZYME SERUM CONTROL?

The FDA product code for ISOENZYME SERUM CONTROL is JJT.

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Other records listing Corning Medical & Scientific 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.

K875122DISPOSABLE STERILE SYRINGE FILTERSK872273CORNING EASY WASH ELISA PLATESK872076CORNING DISPOSABLE ROLLER BOTTLESK863789CORNING ELISA PLATESK854024CORNING MAGIC MAB HCG RADIOIMMUNOASSAYK853634CORNING CELL WELLS-MULTIPLE WELL PLATES

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Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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