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FDA 510(k)

GEMENI CK-MB ISOENZYME ABNORMAL SERUM

K-Number: K810870 · 1981-04-14

ApplicantGemini, Inc.
Decision Date1981-04-14
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GEMENI CK-MB ISOENZYME ABNORMAL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Gemini, Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810870. 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 GEMENI CK-MB ISOENZYME ABNORMAL SERUM?

GEMENI CK-MB ISOENZYME ABNORMAL SERUM is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Gemini, Inc.. The 510(k) number is K810870.

When did GEMENI CK-MB ISOENZYME ABNORMAL SERUM receive FDA 510(k) clearance?

GEMENI CK-MB ISOENZYME ABNORMAL SERUM received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810870.

Who is the listed applicant for GEMENI CK-MB ISOENZYME ABNORMAL SERUM?

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

What is the FDA product code for GEMENI CK-MB ISOENZYME ABNORMAL SERUM?

The FDA product code for GEMENI CK-MB ISOENZYME ABNORMAL SERUM is JJT.

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Other records listing Gemini, 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.

K810534GEMENI QUICK-MB SEPARATION KIT

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

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