The following data is part of a premarket notification filed by Advanced Biomedical Methods, Inc. with the FDA for Resubmission Of The Kleerzit Reagent.
| Device ID | K864866 |
| 510k Number | K864866 |
| Device Name: | RESUBMISSION OF THE KLEERZIT REAGENT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Contact | Jack M Goldberg |
| Correspondent | Jack M Goldberg ADVANCED BIOMEDICAL METHODS, INC. P.O. BOX 48026 Niles, IL 60648 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-11 |
| Decision Date | 1987-03-16 |