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."
1–24 of 159
Search insights Median review: 38d Cleared: 100% Top manufacturer: Miles Laboratories, Inc. Lead specialty: Chemistry
Cleared May 26, 1988
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · FPB
Miles Laboratories, Inc.
General Hospital · 104d
Cleared Apr 28, 1988
MICRO-BUMINTEST REAGENT TABLETS
K874909 · JIR
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Apr 05, 1988
MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE
K875079 · CKA
Miles Laboratories, Inc.
Chemistry · 118d
Cleared Dec 22, 1987
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · CGA
Miles Laboratories, Inc.
Chemistry · 225d
Cleared Oct 28, 1987
SERALYZER III BLOOD CHEMISTRY ANALYZER
K872120 · JJF
Miles Laboratories, Inc.
Chemistry · 149d
Cleared Sep 11, 1987
CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
K873304 · LJX
Miles Laboratories, Inc.
Hematology · 24d
Cleared Aug 04, 1987
CUTTER PUREFLO PLUS IV FILTER
K872634 · FPB
Miles Laboratories, Inc.
General Hospital · 29d
Cleared Jun 29, 1987
MODIFIED SALTEX REAGENT STRIPS
K870214 · CHK
Miles Laboratories, Inc.
Chemistry · 160d
Cleared Apr 14, 1987
SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS
K870752 · CFJ
Miles Laboratories, Inc.
Chemistry · 48d
Cleared Feb 18, 1987
SERA-TEK MICROSOMAL ANTIBODY TEST
K865053 · JZO
Miles Laboratories, Inc.
Chemistry · 56d
Cleared Feb 18, 1987
SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI.
K864530 · CGA
Miles Laboratories, Inc.
Chemistry · 93d
Cleared Feb 02, 1987
SERA-TEK THYROGLOBULIN ANTIBODY TEST
K865020 · DDC
Miles Laboratories, Inc.
Immunology · 41d
Cleared Jan 14, 1987
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT
K863842 · KLT
Miles Laboratories, Inc.
Toxicology · 105d
Cleared Aug 12, 1986
GLUCOFACTS DATA MANAGEMENT SYSTEM
K861844 · JQP
Miles Laboratories, Inc.
Chemistry · 91d
Cleared Aug 08, 1986
GLUCOFACTS DATA PRINTER
K861779 · JQP
Miles Laboratories, Inc.
Chemistry · 92d
Cleared Jul 02, 1986
CLINIFACTS 200 DATA MANAGEMENT SYSTEM
K861778 · JQP
Miles Laboratories, Inc.
Chemistry · 55d
Cleared Jul 02, 1986
GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER
K861303 · CGA
Miles Laboratories, Inc.
Chemistry · 86d
Cleared Jul 02, 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · CGA
Miles Laboratories, Inc.
Chemistry · 188d
Cleared Feb 11, 1986
GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD
K855203 · FMK
Miles Laboratories, Inc.
General & Plastic Surgery · 47d
Cleared Jan 22, 1986
SERALYZER TOTAL BILIRUBIN CALIBRATORS
K855040 · JIS
Miles Laboratories, Inc.
Chemistry · 36d
Cleared Sep 30, 1985
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
K852946 · DLZ
Miles Laboratories, Inc.
Toxicology · 81d
Cleared Sep 03, 1985
TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE
K852611 · CDM
Miles Laboratories, Inc.
Chemistry · 76d
Cleared Aug 23, 1985
GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT
K851703 · CGA
Miles Laboratories, Inc.
Chemistry · 121d
Cleared Aug 12, 1985
VISIDEX II REAGENT STRIPS
K852747
Miles Laboratories, Inc.
Chemistry · 46d