The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Wescor Gram Stain Pack For Model 7300 Aerospray.
| Device ID | K881512 |
| 510k Number | K881512 |
| Device Name: | WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY |
| Classification | Stains, Microbiologic |
| Applicant | WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
| Contact | Wayne K Barlow |
| Correspondent | Wayne K Barlow WESCOR, INC. 459 SOUTH MAIN Logan, UT 84321 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-04-18 |