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

159 results for "Miles Laboratories, Inc."
49–72 of 159
Search insights Median review: 38d Cleared: 100% Top manufacturer: Miles Laboratories, Inc. Lead specialty: Chemistry
Cleared Sep 29, 1983
AMES TDA KANAMYCIN TEST-CONTROL SERUM
K832769 · KJI
Miles Laboratories, Inc.
Chemistry · 44d
Cleared Sep 29, 1983
AMES TDA DISOPYRAMIDE TEST
K832766 · KLT
Miles Laboratories, Inc.
Toxicology · 44d
Cleared Sep 20, 1983
SERA-TEK MYCOPLASMA ANTIBODY TEST
K832132 · GSB
Miles Laboratories, Inc.
Immunology · 81d
Cleared Sep 08, 1983
DIASTIX REAGENT STRIPS FOR URINALYSIS
K831600 · JIL
Miles Laboratories, Inc.
Chemistry · 113d
Cleared Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046 · JIX
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Aug 08, 1983
VISIDEX II REAGENT STRIPS
K831989 · CGA
Miles Laboratories, Inc.
Toxicology · 48d
Cleared Jul 28, 1983
TISSUE-TEK V.I.P. 100/200
K831313 · IEO
Miles Laboratories, Inc.
Pathology · 97d
Cleared Jun 30, 1983
AMWA TDA THEOPHYLLINE TEST
K831514 · LER
Miles Laboratories, Inc.
Toxicology · 49d
Cleared Jun 02, 1983
AMES TDA PROCAINAMIDE TEST
K831400 · LAR
Miles Laboratories, Inc.
Immunology · 34d
Cleared Jun 02, 1983
AMES TDA N-ACETYL-PROCAINAMIDE TEST
K831399 · LAN
Miles Laboratories, Inc.
Immunology · 34d
Cleared May 25, 1983
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · JTT
Miles Laboratories, Inc.
Microbiology · 76d
Cleared Apr 12, 1983
AMES TDA VALPROIC ACID TEST
K830789 · LEG
Miles Laboratories, Inc.
Chemistry · 29d
Cleared Jan 14, 1983
AMES TDA ETHOSUXIMIDE TEST
K823801 · DLF
Miles Laboratories, Inc.
Chemistry · 28d
Cleared Dec 15, 1982
AMES TDA GENTAMICIN TEST
K821669 · DJB
Miles Laboratories, Inc.
Chemistry · 191d
Cleared Nov 29, 1982
CLINISTAT TDA SERIES
K823112 · KHO
Miles Laboratories, Inc.
Toxicology · 39d
Cleared Oct 08, 1982
FLUOROSTAT FLUOROMETER
K822701 · KHO
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN CALIBRATORS
K822046 · KRZ
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN TEST MODULE
K822045 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 30, 1982
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · KHG
Miles Laboratories, Inc.
Hematology · 18d
Cleared Jul 06, 1982
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · KQO
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 21, 1982
ACCUDEX REAGENT STRIPS
K821247 · CGA
Miles Laboratories, Inc.
Chemistry · 22d
Cleared May 14, 1982
VISIDEX REAGENT STRIPS
K821179 · CGA
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Apr 16, 1982
SERALYZER CK REAGENT STRIPS
K820880 · CGS
Miles Laboratories, Inc.
Chemistry · 17d
Cleared Jan 26, 1982
SERALYZER CREATININE REAGENT STRIPS
K820075 · CGX
Miles Laboratories, Inc.
Chemistry · 14d