The following data is part of a premarket notification filed by Miles Inc., Dental Products with the FDA for Clinitek Atlas Automated Urine Chemistry System.
| Device ID | K932674 |
| 510k Number | K932674 |
| Device Name: | CLINITEK ATLAS AUTOMATED URINE CHEMISTRY SYSTEM |
| Classification | Automated Urinalysis System |
| Applicant | MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend, IN 46614 |
| Contact | Rosanne M Soval |
| Correspondent | Rosanne M Soval MILES INC., DENTAL PRODUCTS 4315 S. LAFAYETTE BLVD. South Bend, IN 46614 |
| Product Code | KQO |
| CFR Regulation Number | 862.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-02 |
| Decision Date | 1993-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414374109 | K932674 | 000 |
| 00630414373201 | K932674 | 000 |
| 00630414373027 | K932674 | 000 |
| 00630414373003 | K932674 | 000 |
| 00630414372464 | K932674 | 000 |
| 00630414372181 | K932674 | 000 |