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."
25–41 of 41
Search insights Median review: 28d Cleared: 100% Top manufacturer: Sterling Diagnostics, Inc. Lead specialty: Chemistry
Cleared Mar 03, 1986
HEMOGLOBIN REAGENT SET
K860475 · KHG
Sterling Diagnostics, Inc.
Hematology · 24d
Cleared Feb 28, 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · CJA
Sterling Diagnostics, Inc.
Chemistry · 16d
Cleared Feb 28, 1986
LACTATE DEHYDROGENASE (LDH) REAGENT SET
K860349 · CFH
Sterling Diagnostics, Inc.
Chemistry · 29d
Cleared Feb 24, 1986
SICKLE CELL REAGENT SET
K860420 · GHM
Sterling Diagnostics, Inc.
Hematology · 20d
Cleared Feb 19, 1986
SERUM ALBUMIN (BCG) REAGENT SET
K860340 · CIX
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Feb 19, 1986
ENZYNATIC TRIGLYCERIDES REAGENT SET
K855164 · CDT
Sterling Diagnostics, Inc.
Chemistry · 55d
Cleared Feb 11, 1986
UREA NITROGEN REAGENT SET
K860419 · CDW
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
CREATININE REAGENT SET
K860418 · CGX
Sterling Diagnostics, Inc.
Chemistry · 7d
Cleared Feb 11, 1986
ALKALINE PHOSPHATASE REAGENT SET
K860351 · CIO
Sterling Diagnostics, Inc.
Chemistry · 12d
Cleared Feb 11, 1986
TOTAL PROTEIN (BIURET) REAGENT SET
K860341 · CEK
Sterling Diagnostics, Inc.
Chemistry · 13d
Cleared Feb 11, 1986
MAGNESIUM REAGENT SET
K860215 · JGJ
Sterling Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 11, 1986
URIC ACID REAGENT SET (COLORIMETRIC)
K860142 · LFQ
Sterling Diagnostics, Inc.
Chemistry · 28d
Cleared Feb 11, 1986
CPK REAGENT SET (COLORIMETRIC)
K860096 · CGS
Sterling Diagnostics, Inc.
Chemistry · 32d
Cleared Feb 11, 1986
CALCIUM (CPC) REAGENT SET
K860044 · CIC
Sterling Diagnostics, Inc.
Chemistry · 36d
Cleared Feb 06, 1986
BUN (ENZYMATIC BERTHELOT) REAGENT SET
K860154 · CDL
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jan 28, 1986
TOTAL CHOLESTEROL REAGENT SET
K855028 · CHH
Sterling Diagnostics, Inc.
Chemistry · 43d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · CGA
Sterling Diagnostics, Inc.
Chemistry · 25d