Sigma Diagnostics, Inc. - FDA 510(k) Cleared Devices

Cleared Dec 04, 1985

CK(OPTIMIZED) REAGENT

K854501 · CGS

Chemistry · 22d

Cleared Nov 25, 1985

ALT(OPTIMIZED) REAGENT

K854502 · CKA

Chemistry · 13d

Cleared Nov 25, 1985

AST(OPTIMIZED) REAGENT

K854503 · CIT

Chemistry · 13d

Cleared Oct 28, 1985

SIGMA 610 FOR PROTEIN IN URINE & CSF

K853681 · CEK

Chemistry · 54d

Cleared Oct 22, 1985

GRAM STAIN KIT

K853896 · JTS

Pathology · 32d

Cleared Aug 19, 1985

URIC ACID REAGENT

K853357 · KNK

Chemistry · 7d

Cleared Jun 10, 1985

GLUCOSE(TRINDER) REAGENT

K852130 · CGA

Chemistry · 25d

Cleared Jun 10, 1985

BUN(ENDPOINT) REAGENT

K852131 · CDQ

Chemistry · 25d

Cleared Mar 20, 1985

BUN (RATE) REAGENT

K850923 · CDQ

Chemistry · 15d

Cleared Feb 12, 1985

Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT

K850319 · JQB

Chemistry · 15d

Cleared Dec 11, 1984

TRIGLYCERIDE CALIBRATOR

K844468 · JIT

Chemistry · 22d

Cleared Nov 09, 1984

TRIGLYCERIDE REAGENT

K844032 · CDT

Chemistry · 25d

Cleared Jun 14, 1984

SIGMS PROCED. 228 UV LACTATE DEHYDRO

K841917 · CFJ

Chemistry · 36d

Cleared Jun 14, 1984

SIGMA PROCED. 245 ALKALINE PHOSPHATASE

K841918 · CJE

Chemistry · 36d