K020523 is an FDA 510(k) clearance for the BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757. This device is classified as a Allergen And Vaccine Delivery Needles (Class II - Special Controls, product code SCL).
Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on March 20, 2002, 29 days after receiving the submission on February 19, 2002.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570. 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..
| 510(k) Number | K020523 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2002 |
| Decision Date | March 20, 2002 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | SCL - Allergen And Vaccine Delivery Needles |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5570 |
| Definition | 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. |