The following data is part of a premarket notification filed by Wescor, Inc. with the FDA for Wescor Model 7300 Aerospray Gram Stainer.
Device ID | K881592 |
510k Number | K881592 |
Device Name: | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER |
Classification | Slide Stainer, Automated |
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 | KPA |
CFR Regulation Number | 864.3800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-12 |
Decision Date | 1988-05-13 |