The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Spq Test System Ii For Fib (serum Protein Quanti.).
| Device ID | K900939 |
| 510k Number | K900939 |
| Device Name: | SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.) |
| Classification | System, Fibrinogen Determination |
| Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Contact | John G Yager |
| Correspondent | John G Yager INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
| Product Code | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-28 |
| Decision Date | 1990-05-16 |