The following data is part of a premarket notification filed by George King Bio-medical, Inc. with the FDA for Positive Lupus Anticoagulant Plasma.
| Device ID | K945856 |
| 510k Number | K945856 |
| Device Name: | POSITIVE LUPUS ANTICOAGULANT PLASMA |
| Classification | Control, Plasma, Abnormal |
| Applicant | George King Bio-Medical, Inc. 11771 WEST 112TH ST. Overland Park, KS 66210 |
| Contact | Judith A Gillissen |
| Correspondent | Judith A Gillissen George King Bio-Medical, Inc. 11771 WEST 112TH ST. Overland Park, KS 66210 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815696021112 | K945856 | 000 |
| 00815696020849 | K945856 | 000 |
| 00815696020450 | K945856 | 000 |
| 00815696020443 | K945856 | 000 |
| 00815696020436 | K945856 | 000 |
| 00815696021143 | K945856 | 000 |