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

Filters: Toxicology ×
3,029 results
1969–1992 of 3,029
Search insights Median review: 57d Cleared: 100% Top manufacturer: Syva Co. Lead specialty: Toxicology
Cleared Oct 13, 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · JJQ
Pharmacia, Inc.
Toxicology · 59d
Cleared Oct 11, 1988
TDX CANNABINOIDS-GS
K883731 · LDJ
Abbott Laboratories
Toxicology · 41d
Cleared Oct 11, 1988
EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A
K883920 · DLJ
Syva Co.
Toxicology · 25d
Cleared Oct 11, 1988
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K884022 · DKZ
Syva Co.
Toxicology · 19d
Cleared Oct 06, 1988
MICROMEDIC CRACKPOT RIA KIT
K880674 · KLN
Icn Micromedic Systems
Toxicology · 230d
Cleared Oct 06, 1988
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL
K883147 · JJY
Utak Laboratories, Inc.
Toxicology · 72d
Cleared Sep 19, 1988
BARBITURATE ENZYME IMMUNOASSAY KIT
K882663 · DIS
General Diagnostics
Toxicology · 84d
Cleared Sep 19, 1988
EMIT (R) HVA NEGATIVE URINE
K883210 · DIF
Syva Co.
Toxicology · 52d
Cleared Sep 09, 1988
URINE TOXICOLOGY STANDARD
K881320 · DKB
Verichem Laboratories, Inc.
Toxicology · 165d
Cleared Sep 09, 1988
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459 · JXM
Diagnostic Products Corp.
Toxicology · 28d
Cleared Sep 02, 1988
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · DJG
Roche Diagnostic Systems, Inc.
Toxicology · 77d
Cleared Aug 29, 1988
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD
K881868 · DPM
Supelco, Inc.
Toxicology · 118d
Cleared Aug 29, 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · LDJ
Syva Co.
Toxicology · 87d
Cleared Aug 29, 1988
EMIT QST CARBAMAZEPINE ASSAY
K882961 · KLT
Syva Co.
Toxicology · 46d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Aug 08, 1988
SOLID PHASE EXTRACTION TUBES
K881361 · DJY
Supelco, Inc.
Toxicology · 174d
Cleared Aug 08, 1988
REVISED DOUBLE ANTIBODY AMPHETAMINE
K882228 · DJP
Diagnostic Products Corp.
Toxicology · 81d
Cleared Aug 08, 1988
EMIT HVA BARBITURATE ASSAY
K882611 · DIS
Syva Co.
Toxicology · 45d
Cleared Aug 08, 1988
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653
K882719 · LDP
Em Diagnostic Systems, Inc.
Toxicology · 38d
Cleared Aug 08, 1988
EMIT HVA CANNABINOID 100 NG ASSAY
K882819 · LDJ
Syva Co.
Toxicology · 31d
Cleared Aug 04, 1988
ETHYL ALCOHOL STANDARD
K882117 · DNN
Verichem Laboratories, Inc.
Toxicology · 77d
Cleared Aug 04, 1988
GEMINII GAMMA COUNTER
K882194 · JJE
Laboratory Technologies, Inc.
Toxicology · 71d
Cleared Aug 02, 1988
EMIT HVA OPIATE ASSAY
K881941 · DJG
Syva Co.
Toxicology · 85d
Cleared Aug 02, 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · DKZ
Syva Co.
Toxicology · 40d