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

38 results for "Casco Standards"
1–24 of 38
Search insights Median review: 57d Cleared: 100% Top manufacturer: Casco Standards Lead specialty: Chemistry
Cleared Apr 24, 1998
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K981436 · JIX
Casco Standards
Chemistry · 10d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · JJY
Casco Standards
Microbiology · 198d
Cleared Sep 13, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629 · JIX
Casco Standards
Chemistry · 70d
Cleared Jul 22, 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
K962630 · JJY
Casco Standards
Chemistry · 17d
Cleared Jul 22, 1996
DOCUMENT CARDIAC ASSAYED CONTROL
K961750 · JJY
Casco Standards
Chemistry · 77d
Cleared Mar 22, 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244 · DIF
Casco Standards
Chemistry · 66d
Cleared Dec 20, 1995
DOCUMENT TDM ULTRA UNASSAYED CONTROL
K955155 · DIF
Casco Standards
Chemistry · 37d
Cleared Apr 11, 1995
DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET
K950469 · JJY
Casco Standards
Chemistry · 67d
Cleared Jan 17, 1995
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
K945718 · JJX
Casco Standards
Chemistry · 57d
Cleared Dec 09, 1994
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315 · JJY
Casco Standards
Chemistry · 38d
Cleared Nov 30, 1994
DOCUMENT R AMMONIA/ETHANOL CONTROL
K944361 · JJX
Casco Standards
Chemistry · 84d
Cleared Nov 15, 1994
DOCUMENTR AMMONIA/ETHANOLCALIBRATOR
K944639 · JIX
Casco Standards
Chemistry · 55d
Cleared Nov 15, 1994
DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST SET
K944338 · JJX
Casco Standards
Chemistry · 70d
Cleared Apr 05, 1994
DOCUMENT(R) ZERO
K940568 · JJX
Casco Standards
Chemistry · 56d
Cleared Aug 02, 1993
DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET
K932870 · JJX
Casco Standards
Chemistry · 49d
Cleared Jun 29, 1993
DOCUMENT ENZYME
K932458 · JJY
Casco Standards
Chemistry · 39d
Cleared May 12, 1993
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
K931139 · JJY
Casco Standards
Chemistry · 68d
Cleared Jan 11, 1993
DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD
K924493 · JJX
Casco Standards
Chemistry · 136d
Cleared Nov 05, 1992
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
K923821 · JJX
Casco Standards
Chemistry · 98d
Cleared Nov 05, 1992
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET
K923795 · JJY
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
K923794 · JJX
Casco Standards
Chemistry · 100d
Cleared Nov 05, 1992
DOCUMENT CHEM III CALIBRATION VERIFICATION TEST
K923793 · JJX
Casco Standards
Chemistry · 100d
Cleared Feb 06, 1992
DOCUMENT CK ISOENZYMES CONTROL
K915792 · CDP
Casco Standards
Chemistry · 44d
Cleared Sep 13, 1991
TDM I LINEARITY TEST SET
K913309 · DIF
Casco Standards
Chemistry · 50d