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

77 results for "Diagnostic Chemicals, Ltd. (Usa)"
1–24 of 77
Search insights Median review: 43d Cleared: 100% Top manufacturer: Diagnostic Chemicals, Ltd. (Usa) Lead specialty: Chemistry
Cleared Aug 23, 2002
IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
K022538 · JIR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Feb 12, 1998
BILIRUBIN-SL (TOTAL) ASSAY
K974874 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Aug 02, 1994
AMMONIA ASSAY CAT. NO. 200-02
K932556 · JIF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 433d
Cleared Dec 10, 1993
HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)
K932766 · LBR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 185d
Cleared Aug 19, 1993
DC-LINEATE CAT. NO. SE-091
K932555 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 85d
Cleared Mar 18, 1993
DC-UIBC-CAL
K925877 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 119d
Cleared Jul 26, 1991
MAGNESIUM ASSAY KIT, CAT.# 100-12
K912825 · JGJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 30d
Cleared Jan 08, 1991
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 454d
Cleared Dec 26, 1990
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · LIP
Diagnostic Chemicals, Ltd. (Usa)
Microbiology · 441d
Cleared Nov 20, 1990
ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14
K904660 · JFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 36d
Cleared Jun 12, 1990
ENZYMATIC THEOPHYLLINE REAGENT, #500-82
K901510 · KLS
Diagnostic Chemicals, Ltd. (Usa)
Toxicology · 74d
Cleared Dec 12, 1989
CALCIUM, CATALOGUE NUMBER140-20
K895873 · CJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Jan 11, 1989
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13
K885097 · LDP
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 33d
Cleared Dec 05, 1988
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
K883148 · DHA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 132d
Cleared Nov 01, 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 245d
Cleared Aug 30, 1988
DC-LIQUICAL CATALOGUE #SE-030
K882258 · JIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 91d
Cleared Jul 21, 1988
DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
K882259 · JIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 51d
Cleared May 27, 1988
ASPARTATE AMINOTRANSFERASE ASSAY KIT (IFCC)
K880692 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 95d
Cleared Apr 28, 1988
CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
K880866 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 58d
Cleared Apr 19, 1988
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · JFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 49d
Cleared Apr 18, 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 38d
Cleared Apr 18, 1988
GLUCOSE (TRINDER) CAT. # 220-32
K875211 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
CHLORIDE CAT. # 152-17
K875208 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d
Cleared Apr 18, 1988
ALBUMIN CAT. # 201-03
K875207 · CIX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 122d