The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Dhea (dsl 8900).
| Device ID | K921534 |
| 510k Number | K921534 |
| Device Name: | DSL DHEA (DSL 8900) |
| Classification | Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry |
| Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Contact | Johnny R Willlis |
| Correspondent | Johnny R Willlis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
| Product Code | JKL |
| CFR Regulation Number | 862.1060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-31 |
| Decision Date | 1992-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590211622 | K921534 | 000 |