Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

48 results for "Stanbio Laboratory"
25–48 of 48
Search insights Median review: 60d Cleared: 100% Top manufacturer: Stanbio Laboratory Lead specialty: Chemistry
Cleared Jun 01, 1987
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · JFJ
Stanbio Laboratory
Chemistry · 96d
Cleared Apr 17, 1985
ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870
K851278 · LDP
Stanbio Laboratory
Toxicology · 16d
Cleared Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · JHJ
Stanbio Laboratory
Chemistry · 81d
Cleared Feb 03, 1984
FERTITUBE PREGNANCY TEST #1120
K832867 · JHJ
Stanbio Laboratory
Chemistry · 163d
Cleared Oct 04, 1983
QUICK-TELL INDIRECT PREGNANCY TEST
K832640 · JHJ
Stanbio Laboratory
Chemistry · 61d
Cleared Sep 12, 1983
FERTITELL DIRECT PREGNANCY TEST #1100
K832557 · JHJ
Stanbio Laboratory
Chemistry · 42d
Cleared Aug 31, 1983
ENZYMATIC TRIGLYCERIDES #2000
K832444 · CDT
Stanbio Laboratory
Chemistry · 37d
Cleared Aug 16, 1983
UNITIZED ENZYMATIC GLUCOSE TEST SET
K832159 · CGA
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 22, 1983
URIC-ACID TEST ENZYMATIC COLORIMETRIC
K831864 · KNK
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 22, 1983
CHOLESTEROL-ENZYMATIC REAGENT SET
K831863 · CHH
Stanbio Laboratory
Chemistry · 42d
Cleared Jul 22, 1983
TRIGLYCERIDES REAGENT SET
K831858 · CDT
Stanbio Laboratory
Chemistry · 42d
Cleared Nov 29, 1982
BARBITURATE TEST SET #0550-050
K823237 · DJN
Stanbio Laboratory
Toxicology · 28d
Cleared Dec 22, 1981
BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL
K813349 · DIF
Stanbio Laboratory
Microbiology · 25d
Cleared Feb 02, 1981
STANBIO BILIRUBIN TEST SET
K810055 · CIG
Stanbio Laboratory
Chemistry · 20d
Cleared Jun 20, 1980
STANBIO ACETAMINOPHEN TEST SET #0850
K801014 · LDP
Stanbio Laboratory
Toxicology · 53d
Cleared Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693 · CKE
Stanbio Laboratory
Chemistry · 20d
Cleared Feb 13, 1980
STANBIO DIRECT URIC ACID TEST SET #0770
K800190 · CDH
Stanbio Laboratory
Chemistry · 15d
Cleared Dec 04, 1978
IRON BINDING CAPICITY MODEL 0370
K781865 · JIY
Stanbio Laboratory
Chemistry · 28d
Cleared Oct 03, 1978
CHLORIDE TEST SET, CAT.# 0210
K781635 · CHJ
Stanbio Laboratory
Toxicology · 11d
Cleared May 26, 1978
SR-PLUS DIRECT CHOLESTEROL TEST
K780545 · CGO
Stanbio Laboratory
Chemistry · 53d
Cleared Mar 03, 1978
CSF TOTAL PROTEIN TEST SET #0340
K780110 · JGQ
Stanbio Laboratory
Chemistry · 43d
Cleared Dec 22, 1977
ALKALINE PHOSPHATASE TEST SET
K772257 · CIO
Stanbio Laboratory
Chemistry · 17d
Cleared Nov 03, 1977
DIR. QUANT. COLOR. DETERM. SERUM CREAT.
K771856 · CGX
Stanbio Laboratory
Chemistry · 35d
Cleared Oct 07, 1977
QUAN. COLOR. DETER. OF SERUM ALBUMIN
K771771 · DCF
Stanbio Laboratory
Immunology · 18d