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)"
25–48 of 77
Search insights Median review: 43d Cleared: 100% Top manufacturer: Diagnostic Chemicals, Ltd. (Usa) Lead specialty: Chemistry
Cleared Feb 11, 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 101d
Cleared Feb 02, 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 02, 1988
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69
K875206 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · CKB
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Jan 21, 1988
SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM
K874284 · JHT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 99d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 47d
Cleared Feb 20, 1987
SALICYLATE ASSAY KIT, CATALOGUE NUMBER 501-71
K870336 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Aug 19, 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 12, 1986
MODEL 303-42/303-43 ASPARTATE AMINOTRANSFERASE KIT
K862832 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 18d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Apr 21, 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 28d
Cleared Mar 17, 1986
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 26d
Cleared Aug 02, 1985
UREASE & GLUTAMATE DEHYDROGENASE, UREA NITROGEN
K853102 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 10d
Cleared Aug 02, 1985
DC LIQUITROL LEVEL 1 & 2
K852753 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 35d
Cleared Jul 12, 1985
X-AMYLASE ASSAY KIT
K852636 · CIJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 22d
Cleared Jul 12, 1985
DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
K852595 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
DC-LIP, CATALOGUE NUMBER SE-020
K852594 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 12, 1985
CHLORIDE ASSAY KIT
K852058 · CHJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 64d
Cleared Mar 19, 1985
GLUTAMYLTRANSFERASE ASSAY KIT
K850788 · JPZ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 21d
Cleared Oct 22, 1984
SALICYLATE ASSAY KIT
K842158 · DKJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 145d
Cleared Oct 11, 1984
TRIGLYCERIDE ASSAY KIT GPO-CP
K843536 · CDT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 34d
Cleared Oct 05, 1984
STANDARDS & ACCESSORIES FOR NOVA INSTRU
K842873 · JGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 74d
Cleared Sep 28, 1984
VMA ASSAY KIT
K843379 · CDF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d