Company ยท US
Miles Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1988. Name variants (Inc, Corp, punctuation) are merged.
158510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CGA | Glucose Oxidase, Glucose | 12 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 8 |
| KQO | Automated Urinalysis System | 6 |
| CDX | Radioimmunoassay, Total Thyroxine | 4 |
| IEO | Processor, Tissue, Automated | 4 |
| KHG | Whole Blood Hemoglobin Determination | 4 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 3 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 3 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 3 |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 |
| KLT | Enzyme Immunoassay, Carbamazepine | 3 |
| LER | Fluorescent Immunoassay, Theophylline | 3 |
| LET | Fluorescent Immunoassay, Phenobarbital | 3 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| FPB | Filter, Infusion Line | 2 |
| JIS | Calibrator, Primary | 2 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 26, 1988 | K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER Miles Laboratories, Inc. | FPB |
| Apr 28, 1988 | K874909 | MICRO-BUMINTEST REAGENT TABLETS Miles Laboratories, Inc. | JIR |
| Apr 5, 1988 | K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE Miles Laboratories, Inc. | CKA |
| Dec 22, 1987 | K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT Miles Laboratories, Inc. | CGA |
| Oct 28, 1987 | K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER Miles Laboratories, Inc. | JJF |
| Sep 11, 1987 | K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) Miles Laboratories, Inc. | LJX |
| Aug 4, 1987 | K872634 | CUTTER PUREFLO PLUS IV FILTER Miles Laboratories, Inc. | FPB |
| Jun 29, 1987 | K870214 | MODIFIED SALTEX REAGENT STRIPS Miles Laboratories, Inc. | CHK |
| Apr 14, 1987 | K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS Miles Laboratories, Inc. | CFJ |
| Feb 18, 1987 | K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST Miles Laboratories, Inc. | JZO |
| Feb 18, 1987 | K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. Miles Laboratories, Inc. | CGA |
| Feb 2, 1987 | K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST Miles Laboratories, Inc. | DDC |
| Jan 14, 1987 | K863842 | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT Miles Laboratories, Inc. | KLT |
| Aug 12, 1986 | K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. | JQP |
| Aug 8, 1986 | K861779 | GLUCOFACTS DATA PRINTER Miles Laboratories, Inc. | JQP |
| Jul 2, 1986 | K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. | JQP |
| Jul 2, 1986 | K861303 | GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER Miles Laboratories, Inc. | CGA |
| Jul 2, 1986 | K855202 | GLUCOMETER M BLOOD GULCOSE METER Miles Laboratories, Inc. | CGA |
| Feb 11, 1986 | K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD Miles Laboratories, Inc. | FMK |
| Jan 22, 1986 | K855040 | SERALYZER TOTAL BILIRUBIN CALIBRATORS Miles Laboratories, Inc. | JIS |
| Sep 30, 1985 | K852946 | SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT Miles Laboratories, Inc. | DLZ |
| Sep 3, 1985 | K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE Miles Laboratories, Inc. | CDM |
| Aug 23, 1985 | K851703 | GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT Miles Laboratories, Inc. | CGA |
| Aug 12, 1985 | K852747 | VISIDEX II REAGENT STRIPS Miles Laboratories, Inc. | |
| Aug 7, 1985 | K853021 | OPTIMATE DIGOXIN TEST Miles Laboratories, Inc. | DPB |
| Jun 10, 1985 | K852117 | CYTO-TEK CENTRIFUGE Miles Laboratories, Inc. | IFB |
| Mar 19, 1985 | K844955 | SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & Miles Laboratories, Inc. | CEM |
| Mar 19, 1985 | K842092 | SERALYZER ARIS PHENYTOIN REAGENT STRIPS Miles Laboratories, Inc. | DIP |
| Jan 18, 1985 | K844907 | CLINIFACTS 10 DATA MANAGEMENT SYSTEM Miles Laboratories, Inc. | JQP |
| Jan 4, 1985 | K843727 | LEUKOSTIX REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. | LJX |
| Aug 28, 1984 | K842470 | TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM Miles Laboratories, Inc. | DFH |
| Aug 28, 1984 | K842468 | TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG Miles Laboratories, Inc. | CZP |
| Aug 24, 1984 | K841041 | CLINI-TEK AUTO 2000 REFLECTANCE SPECTR Miles Laboratories, Inc. | KQO |
| Aug 17, 1984 | K842592 | AMES TDA PHENOBARBITAL TEST Miles Laboratories, Inc. | LET |
| Aug 15, 1984 | K842237 | CLINITEK 200 SEMI-AUTOMATED URINALYSIS Miles Laboratories, Inc. | KQO |
| Jul 25, 1984 | K842238 | CLINITEK 10 SEMI-AUTO URINALYSIS SYS Miles Laboratories, Inc. | KQO |
| Jul 16, 1984 | K842006 | CITOJECT CARTRIDGE SYRINGE Miles Laboratories, Inc. | EJI |
| Jun 22, 1984 | K841816 | OPTIMATE IGG TEST Miles Laboratories, Inc. | DEW |
| Jun 22, 1984 | K841814 | OPTIMATE IGM TEST Miles Laboratories, Inc. | DFT |
| Jun 1, 1984 | K841815 | OPTIMATE IGA TEST Miles Laboratories, Inc. | CZN |
| May 11, 1984 | K841582 | OPTIMATE DIGOXIN TEST Miles Laboratories, Inc. | KXT |
| Mar 19, 1984 | K833977 | SERALYZER DRUG ASSAY CONTROL SERUM Miles Laboratories, Inc. | DLJ |
| Mar 19, 1984 | K832825 | SERALYZER THEOPHYLLINE REAGENT STRIPS Miles Laboratories, Inc. | KLS |
| Oct 28, 1983 | K832088 | AMES TDA NETILMICIN TEST & SERUM Miles Laboratories, Inc. | LCE |
| Oct 14, 1983 | K832791 | SERAYZER ALT/SGPT REAGENT STRIPS Miles Laboratories, Inc. | CKC |
| Oct 14, 1983 | K832790 | SERALYZER AST/SGOT REAGENT STRIPS Miles Laboratories, Inc. | CIF |
| Oct 4, 1983 | K832684 | SERALYZER TRIGLYCERIDES REAGENT STRIPS Miles Laboratories, Inc. | CDT |
| Sep 29, 1983 | K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM Miles Laboratories, Inc. | DJB |
| Sep 29, 1983 | K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM Miles Laboratories, Inc. | KJI |
| Sep 29, 1983 | K832766 | AMES TDA DISOPYRAMIDE TEST Miles Laboratories, Inc. | KLT |
Newest 50 of 158.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||