The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Bactigen(r) Group B Streptococcus Test.
| Device ID | K885003 |
| 510k Number | K885003 |
| Device Name: | BACTIGEN(R) GROUP B STREPTOCOCCUS TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Ann Maclearie |
| Correspondent | Ann Maclearie ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-01 |
| Decision Date | 1989-02-07 |