# Miles Laboratories, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 159 (1976–1988): 158 510(k) clearances and 1 original PMA approval
- Product codes: CGA (12), JQP (8), KQO (6), KHG (4), IEO (4), CDX (4), DJB (3), JJW (3), LET (3), LER (3), JIL (3), KLT (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Abaxis, Inc.: 1 (https://510kreport.com/company/abaxis)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Bayer Corp.: 1 (https://510kreport.com/company/bayer)
- Yeongdong Pharmaceutical Corp.: 1 (https://510kreport.com/company/yeongdong-pharmaceutical)

## Its most-cited devices
- K861844: Glucofacts Data Management System (1986), cited by 1
- K842237: Clinitek 200 Semi-Automated Urinalysis (1984), cited by 1
- K801270: Test for Ketone in Urine (Acetoacetic AC (1980), cited by 1
- K802743: Ames Sera-Pak Cholesterol Reagent Kit (1980), cited by 1

## Recent decisions
- K880605: Labeling Change for Cutter Pureflo Plus IV Filter (May 26, 1988)
- K874909: Micro-Bumintest Reagent Tablets (Apr 28, 1988)
- K875079: Modified Seralyzer Alt/SGPT Reag. Strips & Module (Apr 5, 1988)
- K871835: Glucometer QC Blood Meter, Ames Gluco System Print (Dec 22, 1987)
- K872120: Seralyzer Iii Blood Chemistry Analyzer (Oct 28, 1987)
- K873304: Clinitek Auto 2000 Reagent Cassette (Leukocytes) (Sep 11, 1987)
- K872634: Cutter Pureflo Plus IV Filter (Aug 4, 1987)
- K870214: Modified Saltex Reagent Strips (Jun 29, 1987)

Source page: https://510kreport.com/company/miles-laboratories