Miles, Inc.
Tarrytown, NY, US
Miles, Inc. appears in FDA device records in Tarrytown, NY. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Miles, Inc. between 1993 and 1995. The busiest year on record is 1994, with 5. The most recent is 1995, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1994 | 5 |
| 1995 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K950292 | FOLATE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM, IN VITRO DIAGNOSTIC SYSTEM | CGN | Substantially Equivalent | |
| K950353 | TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | JJE | Substantially Equivalent | |
| K950186 | CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM | JHW | Substantially Equivalent | |
| K945655 | CREATININE (ENZYMATIC UV) PROCEDURE FOR TECHNICON SYSTEMS (IN VITRO DIAGNOSTIC TEST SYSTEM) | CGX | Substantially Equivalent | |
| K941171 | TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) | GKZ | Substantially Equivalent | |
| K943376 | OPERA SYSTEM | JJC | Substantially Equivalent | |
| K941156 | TECHNISON AXON SYSTEM | KHS | Substantially Equivalent | |
| K933682 | DIRECT AMYLASE (EC 3.2.1.1) METHOD FOR TECHNICON SYSTEMS | JFJ | Substantially Equivalent | |
| K935287 | IRON -II (FE-II) METHOD/TECH CHEM 1(R) 1+TM SYSTEM | JIY | Substantially Equivalent | |
| K933478 | TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 | GKZ | Substantially Equivalent | |
| K933475 | TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 | GKZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JFJCatalytic Methods, Amylase
- GKZCounter, Differential Cell
- KHSEnzymatic, Carbon-Dioxide
- JIYPhotometric Method, Iron (Non-Heme)
- JHWU.V. Method, Cpk Isoenzymes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain