The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Positive And Negative Hcg Urine Controls.
| Device ID | K894181 |
| 510k Number | K894181 |
| Device Name: | POSITIVE AND NEGATIVE HCG URINE CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Ed Zior |
| Correspondent | Ed Zior ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-16 |
| Decision Date | 1989-08-31 |