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

41 results for "Sterling Diagnostics, Inc."
1–24 of 41
Search insights Median review: 28d Cleared: 100% Top manufacturer: Sterling Diagnostics, Inc. Lead specialty: Chemistry
Cleared Jan 21, 1993
MICROPROTEIN REAGENT SET
K921412 · CEK
Sterling Diagnostics, Inc.
Chemistry · 303d
Cleared Nov 07, 1991
TRIGLYCERIDES REAGENT SET
K914609 · CDT
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Oct 31, 1991
SODIUM REAGENT SET
K914039 · CEI
Sterling Diagnostics, Inc.
Chemistry · 51d
Cleared Oct 30, 1991
PHOSPHOLIPID REAGENT SET
K914040 · JNT
Sterling Diagnostics, Inc.
Chemistry · 50d
Cleared Jul 29, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
K862255 · CFJ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 07, 1986
VANILMANDELIC ACID (VMA) REAGENT SET
K861962 · CDF
Sterling Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 01, 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · CJE
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 01, 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · CDQ
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jun 25, 1986
ALT (SGPT) REAGENT SET (UV RATE)
K862209 · CKA
Sterling Diagnostics, Inc.
Chemistry · 15d
Cleared Jun 16, 1986
HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET
K861855 · JKF
Sterling Diagnostics, Inc.
Chemistry · 33d
Cleared May 23, 1986
SERUM POTASSIUM REAGENT SET
K861713 · CEJ
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared May 23, 1986
SALICYLATE REAGENT SET
K861615 · DKJ
Sterling Diagnostics, Inc.
Toxicology · 24d
Cleared Apr 24, 1986
GLUCOSE (HEXOKINASE) REAGENT SET
K861311 · CFR
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Apr 24, 1986
SERUM CHOLINESTERASE REAGENT SET
K860350 · DLI
Sterling Diagnostics, Inc.
Chemistry · 84d
Cleared Apr 03, 1986
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET
K860667 · CIT
Sterling Diagnostics, Inc.
Chemistry · 38d
Cleared Apr 03, 1986
SGPT (ALT) REAGENT SET (COLORIMETRIC)
K860485 · CKD
Sterling Diagnostics, Inc.
Chemistry · 52d
Cleared Apr 03, 1986
URIC ACID REAGNET SET (TRINDER)
K860477 · KNK
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Apr 03, 1986
SGOT (AST) REAGENT SET
K860216 · CIQ
Sterling Diagnostics, Inc.
Chemistry · 71d
Cleared Mar 17, 1986
GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET
K860348 · JPZ
Sterling Diagnostics, Inc.
Chemistry · 46d
Cleared Mar 17, 1986
TOTAL BILIRUBIN REAGENT SET
K860214 · CIG
Sterling Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 14, 1986
INORGANIC PHOSPHORUS REAGENT SET
K860628 · CEO
Sterling Diagnostics, Inc.
Chemistry · 23d
Cleared Mar 14, 1986
SERUM LIPASE REAGENT SET (TURBIDIMETRIC)
K860554 · CFG
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Mar 14, 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478 · JIY
Sterling Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 05, 1986
ACID PHOSPHATASE REAGENT SET
K860476 · CKE
Sterling Diagnostics, Inc.
Chemistry · 26d