The following data is part of a premarket notification filed by Precision Dynamics Corp. with the FDA for Bbl Port-a-cul 21628 Double Swab Sulture Collectio.
| Device ID | K844369 |
| 510k Number | K844369 |
| Device Name: | BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Contact | Gino Franco |
| Correspondent | Gino Franco PRECISION DYNAMICS CORP. POST OFFICE BOX 9043 Van Nuys, CA 91409 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-13 |
| Decision Date | 1985-01-04 |