Stanbio Laboratory - FDA 510(k) Cleared Devices
47
Total
47
Cleared
0
Denied
47 devices
Cleared
Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
Chemistry
81d
Cleared
Feb 03, 1984
FERTITUBE PREGNANCY TEST #1120
Chemistry
163d
Cleared
Oct 04, 1983
QUICK-TELL INDIRECT PREGNANCY TEST
Chemistry
61d
Cleared
Sep 12, 1983
FERTITELL DIRECT PREGNANCY TEST #1100
Chemistry
42d
Cleared
Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
Chemistry
37d
Cleared
Aug 16, 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
Chemistry
42d
Cleared
Jul 22, 1983
TRIGLYCERIDES REAGENT SET
Chemistry
42d
Cleared
Jul 22, 1983
CHOLESTEROL-ENZYMATIC REAGENT SET
Chemistry
42d
Cleared
Jul 22, 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
Chemistry
42d
Cleared
Nov 29, 1982
BARBITURATE TEST SET #0550-050
Toxicology
28d
Cleared
Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
Microbiology
25d
Cleared
Feb 02, 1981
STANBIO BILIRUBIN TEST SET
Chemistry
20d
Cleared
Jun 20, 1980
STANBIO ACETAMINOPHEN TEST SET #0850
Toxicology
53d
Cleared
Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
Chemistry
20d
Cleared
Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
Chemistry
15d
Cleared
Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
Chemistry
28d
Cleared
Oct 03, 1978
CHLORIDE TEST SET, CAT.# 0210
Toxicology
11d
Cleared
May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
Chemistry
53d
Cleared
Mar 03, 1978
CSF TOTAL PROTEIN TEST SET #0340
Chemistry
43d
Cleared
Dec 22, 1977
ALKALINE PHOSPHATASE TEST SET
Chemistry
17d
Cleared
Nov 03, 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
Chemistry
35d
Cleared
Oct 07, 1977
QUAN. COLOR. DETER. OF SERUM ALBUMIN
Immunology
18d