Panels › General Hospital › Product code SCL · Class 2
Allergen And Vaccine Delivery Needles
Regulation 880.5570
1510(k)s in 12 months (25 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SCL
| Company | 510(k)s | Recalls |
|---|---|---|
| Greer Laboratories, Inc. | 2 | 0 |
| Lincoln Diagnostics, Inc. | 2 | 0 |
| Precision Medical Products, Inc. | 2 | 0 |
| Aller/Guard, Inc. | 1 | 0 |
| Aller-Screen, Inc. | 1 | 0 |
| Allergy & Applicator Depot, LLC | 1 | 0 |
| Allergy Extract Co. | 1 | 0 |
| Anhui Tiankang Medical Technology Co., Ltd. | 1 | 0 |
| Asistan Medikal | 1 | 0 |
| Bayer Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2026 | K250983 | Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, Asistan Medikal, TR | SCL |
| Dec 6, 2022 | K222385 | Bifurcated Needle Anhui Tiankang Medical Technology Co., Ltd., CN | SCL |
| Apr 10, 2019 | K182582 | Oryum and Ovem Epidermal Deri Prick Test Applicator Allergy & Applicator Depot, LLC | SCL |
| Mar 5, 2018 | K172062 | AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray Medscience Science Research Group, Inc. | SCL |
| Aug 17, 2017 | K162917 | Allerhope Allergy Skin Tester Procare Industrial Co., Limited, CN | SCL |
| Sep 9, 2003 | K032528 | BD ECLIPSE BIFURCATED NEEDLE Becton, Dickinson & CO | SCL |
| Aug 7, 2003 | K031630 | BIFURCATED ALLERGY SKIN TESTING NEEDLE Precision Medical Products, Inc. | SCL |
| Mar 20, 2002 | K020523 | BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 Bd | SCL |
| Mar 19, 2002 | K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE Univec, Inc. | SCL |
| Sep 19, 2001 | K012515 | BIFURCATED VACCINATING NEEDLE Precision Medical Products, Inc. | SCL |
| Sep 14, 2001 | K011979 | ALLERSHARP ALLERGY SKIN TESTER Hmb Medical Concepts, Ltd. | SCL |
| Dec 13, 2000 | K003195 | GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC Greer Laboratories, Inc. | SCL |
| Apr 28, 2000 | K000299 | DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D Biomedex, Inc. | SCL |
| Sep 2, 1998 | K982578 | QUANTI-TEST SYSTEM Panatrex, Inc. | SCL |
| Aug 7, 1996 | K961918 | MULTI-TEST II Lincoln Diagnostics, Inc. | SCL |
| Nov 13, 1995 | K953939 | QUINTEST Bayer Corp. | SCL |
| Sep 2, 1994 | K941820 | DUOTIP-TEST Lincoln Diagnostics, Inc. | SCL |
| Jun 17, 1993 | K922177 | DISPOSABLE MULTI-PUNCTURE APPLICATOR Allergy Extract Co. | SCL |
| Jun 23, 1989 | K890360 | GREER DERMAPIK SYSTEM Greer Laboratories, Inc. | SCL |
| Aug 9, 1988 | K882360 | DERMAPIK Creative Scientific Equipment Corp. | SCL |
| Feb 8, 1985 | K844221 | HMB ALLERGOGEN SKIN PRICK TEST NEEDLE Aller/Guard, Inc. | SCL |
| Sep 5, 1984 | K842107 | COMBO SKIN TEST READY TO USE TAPE Combion Systems, Inc. | SCL |
| Sep 5, 1984 | K833999 | COMBION SKIN TEST - FOUR PRONG Nicholas H. Maganias | SCL |
| May 30, 1980 | K791328 | ALLER-SCREEN SKIN TEST KIT Aller-Screen, Inc. | SCL |
| Dec 30, 1976 | K760699 | MULTI-TEST Lincoln Laboratories, Inc. | SCL |
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