The following data is part of a premarket notification filed by Greer Laboratories, Inc. with the FDA for Greertrack Skin Testing System, Model Gt-it, Gt-ic.
| Device ID | K003195 |
| 510k Number | K003195 |
| Device Name: | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | GREER LABORATORIES, INC. 639 NUWAY CIRCLE, N.E. P.O. BOX 800 Lenoir, NC 28645 -0800 |
| Contact | Gerald Friesen |
| Correspondent | Gerald Friesen GREER LABORATORIES, INC. 639 NUWAY CIRCLE, N.E. P.O. BOX 800 Lenoir, NC 28645 -0800 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-12 |
| Decision Date | 2000-12-13 |