510(k) K020500
- Device
- UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
- Applicant
- Univec, Inc.
- 510(k) number
- K020500
- Product code
- SCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-19
- Date received
- 2002-02-14
- Regulation
- 880.5570
- Classification name
- Allergen And Vaccine Delivery Needles
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- R. COHEN
- Address
- 22 Dubon Ct. Farmingdale NY US 11735 11735
FDA Registration Numbers#
- 3007590959
- 3009449769
- 3002807310
- 3011088743
- 1011574
- 3015536286
- 1424263
- 8043734
- 3014290918
- 3008812251
- 1061927
- 3010131789
- 3010132111
- 3030554525
- 1047843
- 2248704
- 3017896194
- 1055876
- 2531321
- 1450391
- 1928237
- 3012620142
- 1423507
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SCL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) | Asistan Medikal | 2026-01-30 |
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| K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray | Medscience Science Research Group, Inc. | 2018-03-05 |
| K162917 | Allerhope Allergy Skin Tester | Procare Industrial Co., Limited | 2017-08-17 |
| K032528 | BD ECLIPSE BIFURCATED NEEDLE | Becton, Dickinson & CO | 2003-09-09 |
| K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE | Precision Medical Products, Inc. | 2003-08-07 |
| K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 | Bd | 2002-03-20 |
| K012515 | BIFURCATED VACCINATING NEEDLE | Precision Medical Products, Inc. | 2001-09-19 |
| K011979 | ALLERSHARP ALLERGY SKIN TESTER | Hmb Medical Concepts, Ltd. | 2001-09-14 |
| K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC | Greer Laboratories, Inc. | 2000-12-13 |
| K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D | Biomedex, Inc. | 2000-04-28 |
| K982578 | QUANTI-TEST SYSTEM | Panatrex, Inc. | 1998-09-02 |
| K961918 | MULTI-TEST II | Lincoln Diagnostics, Inc. | 1996-08-07 |
| K953939 | QUINTEST | Bayer Corp. | 1995-11-13 |