The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active I-hcg Irma.
Device ID | K960357 |
510k Number | K960357 |
Device Name: | DSL ACTIVE I-HCG IRMA |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | John Willis |
Correspondent | John Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-25 |
Decision Date | 1996-05-07 |
Summary: | summary |