Container, Specimen Mailer And Storage, Sterile
Regulation 864.3250
0510(k)s in 12 months (12 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in KDT
| Company | 510(k)s | Recalls |
|---|---|---|
| Heritage Labs International LLC | 0 | 17 |
| Preventive Diagnostics Corp. | 2 | 0 |
| Sage Products, Inc. | 2 | 0 |
| American Scientific Products | 1 | 0 |
| Biosure, Inc. | 1 | 0 |
| Dynatech Corp. | 1 | 0 |
| Hospal Medical Corp. | 1 | 0 |
| M.M. Wolfred, Ph.D. | 1 | 0 |
| Perkins Mfg. Co. | 1 | 0 |
| Richard-Allan Medical Ind., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 1987 | K873593 | BIOSURE SPECIMEN COLLECTION CONTAINER Biosure, Inc. | KDT |
| Sep 4, 1986 | K862665 | NOVACYTE-U Xsirius Medical, Inc. | KDT |
| Feb 4, 1984 | K834579 | BIOSPAL 2400S Hospal Medical Corp. | KDT |
| Jan 13, 1984 | K834412 | PRESERV PVA FIXATIVE 15ML-FORMALIN PK Preventive Diagnostics Corp. | KDT |
| Nov 28, 1983 | K833660 | PRESERV PVA FIXATIVE -MALIN PACK Preventive Diagnostics Corp. | KDT |
| Jan 21, 1983 | K823773 | PROVIAL II #006-010-0201 Dynatech Corp. | KDT |
| Nov 1, 1982 | K822870 | STOOL-COLLECTION/PRESERVATION KIT American Scientific Products | KDT |
| Jul 21, 1982 | K821621 | PREGNOPOST M.M. Wolfred, Ph.D. | KDT |
| Feb 18, 1982 | K820246 | PREFILLED SPECIMEN CONTAINER Sage Products, Inc. | KDT |
| Jul 31, 1981 | K811793 | FIX-RIGHT 90ML & 180 ML PREFILLED CONT Richard-Allan Medical Ind., Inc. | KDT |
| Jun 20, 1980 | K800946 | URINARY CATHETER SAMPLING KIT Sage Products, Inc. | KDT |
| Feb 24, 1977 | K770071 | PINLOCK CONTAINER Perkins Mfg. Co. | KDT |
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