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FDA 510(k)

U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL

K-Number: K870737 · 1987-04-13

ApplicantU. S. Diagnostics, Inc.
Decision Date1987-04-13
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is U. S. Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-13 under 510(k) number K870737. 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 U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL?

U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL is a medical device that received FDA 510(k) clearance on 1987-04-13. The listed applicant is U. S. Diagnostics, Inc.. The 510(k) number is K870737.

When did U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL receive FDA 510(k) clearance?

U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL received FDA 510(k) clearance on 1987-04-13, under 510(k) number K870737.

Who is the listed applicant for U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL?

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

What is the FDA product code for U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL?

The FDA product code for U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL is JJT.

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Other records listing U. S. Diagnostics, Inc. as applicant

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Related Devices (Code: JJT)

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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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