The following data is part of a premarket notification filed by Alfa Scientific Designs, Inc. with the FDA for Instant-view Pregnancy Urine Mid-stream Test.
Device ID | K984075 |
510k Number | K984075 |
Device Name: | INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST |
Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant | ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
Contact | Naishu Wang |
Correspondent | Naishu Wang ALFA SCIENTIFIC DESIGNS, INC. 11494 SORRENTO VALLEY RD., SUITE F/M San Diego, CA 92121 |
Product Code | LCX |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-16 |
Decision Date | 1999-02-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50096295141547 | K984075 | 000 |
00667742001117 | K984075 | 000 |
00677421001116 | K984075 | 000 |