510(k) K833999
- Device
- Combion Skin Test - Four Prong
- Applicant
- NICHOLAS H. MAGANIAS
- 510(k) number
- K833999
- Product code
- SCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-05
- Date received
- 1983-11-21
- Regulation
- 880.5570
- Classification name
- Allergen And Vaccine Delivery Needles
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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#
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|---|---|---|---|
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| K020500 | UNIVEC BIFURCATED SLIDING SHEATH SYRINGE | Univec, Inc. | 2002-03-19 |
| 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 |