The following data is part of a premarket notification filed by Lakewood Biochemical Co., Inc. with the FDA for Gram Crystal Violet/iodine/aceton Alchl Declr/safr.
| Device ID | K873413 |
| 510k Number | K873413 |
| Device Name: | GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR |
| Classification | Stains, Microbiologic |
| Applicant | LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
| Contact | John E Pedigo |
| Correspondent | John E Pedigo LAKEWOOD BIOCHEMICAL CO., INC. 2111 IRVING BLVD. Dallas, TX 75207 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-24 |
| Decision Date | 1987-10-06 |