The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Pap Ria -dsl#3100.
Device ID | K844679 |
510k Number | K844679 |
Device Name: | DSL PAP RIA -DSL#3100 |
Classification | Acid Phosphatase (prostatic), Tartrate Inhibited |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Gopal Savjani |
Correspondent | Gopal Savjani DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | JFH |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-30 |
Decision Date | 1985-04-29 |