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

42 results for "Analytical Control Systems, Inc."
1–24 of 42
Search insights Median review: 50d Cleared: 100% Top manufacturer: Analytical Control Systems, Inc. Lead specialty: Hematology
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892 · GFO
Analytical Control Systems, Inc.
Hematology · 295d
Cleared Jul 20, 1994
ACS CARDIO-TROL CONTROL
K941115 · JJY
Analytical Control Systems, Inc.
Chemistry · 135d
Cleared Apr 20, 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · JJX
Analytical Control Systems, Inc.
Chemistry · 98d
Cleared Mar 11, 1994
ACS O DILVENT PROTEIN DILUTION MATRIX
K940397 · JJY
Analytical Control Systems, Inc.
Chemistry · 43d
Cleared Jun 07, 1993
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
K930477 · JIS
Analytical Control Systems, Inc.
Chemistry · 129d
Cleared Apr 27, 1993
ACS APCT REAGENT, MODIFIED
K926012 · GFO
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Mar 23, 1993
COAGULATION CONTROL CONTAINING HEMOGLOBIN
K925340 · JPA
Analytical Control Systems, Inc.
Hematology · 154d
Cleared Feb 18, 1993
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K925906 · JJX
Analytical Control Systems, Inc.
Chemistry · 90d
Cleared Aug 18, 1992
ACS FREEZE-DRIED APTT REAGENT
K921223 · GFO
Analytical Control Systems, Inc.
Hematology · 158d
Cleared Jul 28, 1992
ACS APCT REAGENT
K921118 · GFO
Analytical Control Systems, Inc.
Hematology · 141d
Cleared Dec 04, 1991
ACS ULTRA-1 THROMBOPLASTIN
K913249 · GJS
Analytical Control Systems, Inc.
Hematology · 135d
Cleared Nov 27, 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · GJS
Analytical Control Systems, Inc.
Hematology · 128d
Cleared Sep 25, 1991
ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
K913677 · LAS
Analytical Control Systems, Inc.
Toxicology · 37d
Cleared Aug 09, 1991
ACS LIQUID THROMBOPLASTIN
K912102 · GJS
Analytical Control Systems, Inc.
Hematology · 88d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III
K911178 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II
K911177 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I
K911176 · JJX
Analytical Control Systems, Inc.
Toxicology · 44d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III
K911171 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II
K911170 · JIY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I
K911169 · JJY
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III
K911168 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II
K911167 · DIF
Analytical Control Systems, Inc.
Toxicology · 47d
Cleared May 01, 1991
ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1
K910930 · DIF
Analytical Control Systems, Inc.
Chemistry · 56d
Cleared Dec 26, 1990
ACS CHOLESTREROL/TRIGLYCERIDE LIQUID LINEAR CALIBR
K904767 · JIX
Analytical Control Systems, Inc.
Chemistry · 65d