510(k) K003195
K003195 is an FDA 510(k) premarket notification submitted by Greer Laboratories, Inc. for the device "GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC". The FDA issued a decision of Substantially Equivalent on December 13, 2000. The device falls under product code SCL (Allergen And Vaccine Delivery Needles), a Class II device regulated under 21 CFR 880.5570. Greer Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2000
- Date Received
- October 12, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Allergen And Vaccine Delivery Needles
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.