The following data is part of a premarket notification filed by Pearce Clinical Laboratories, Inc. with the FDA for Diabetes Risk Detector.
| Device ID | K864544 |
| 510k Number | K864544 |
| Device Name: | DIABETES RISK DETECTOR |
| Classification | Method, Enzymatic, Glucose (urinary, Non-quantitative) |
| Applicant | PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Contact | Pearce, Phd |
| Correspondent | Pearce, Phd PEARCE CLINICAL LABORATORIES, INC. 805 NO. SAN JACINTO Conroe, TX 77301 |
| Product Code | JIL |
| CFR Regulation Number | 862.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-19 |
| Decision Date | 1987-07-27 |