The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Urine Pregnancy Test Standard/contr. Pk.
| Device ID | K811150 |
| 510k Number | K811150 |
| Device Name: | URINE PREGNANCY TEST STANDARD/CONTR. PK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-27 |
| Decision Date | 1981-05-15 |