FDA 510(k)

LDH ISOTROL T

K-Number: K770049 · 1977-01-26

Decision Date1977-01-26

Product CodeJJT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LDH ISOTROL T is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1977-01-26 under 510(k) number K770049. 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 LDH ISOTROL T?

LDH ISOTROL T is a medical device that received FDA 510(k) clearance on 1977-01-26. The listed applicant is Sigma Chemical Co.. The 510(k) number is K770049.

When did LDH ISOTROL T receive FDA 510(k) clearance?

LDH ISOTROL T received FDA 510(k) clearance on 1977-01-26, under 510(k) number K770049.

Who is the listed applicant for LDH ISOTROL T?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDH ISOTROL T?

The FDA product code for LDH ISOTROL T is JJT.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: JJT)

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 Corporation K030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLC K021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-Rad K012656LIQUICHEK 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.