The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Pg-numeric(tm).
| Device ID | K883411 |
| 510k Number | K883411 |
| Device Name: | PG-NUMERIC(TM) |
| Classification | Colorimetric Method, Lecithin/sphingomyelin Ratio |
| Applicant | ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Contact | Wendy S Cline |
| Correspondent | Wendy S Cline ISOLAB, INC. DRAWER 4350 Akron, OH 44321 |
| Product Code | JHF |
| CFR Regulation Number | 862.1455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-15 |
| Decision Date | 1989-03-15 |