510(k) K013263
- Device
- FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
- Applicant
- Fred Hutchinson Cancer Research Center
- 510(k) number
- K013263
- Product code
- LKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-29
- Date received
- 2001-10-01
- Regulation
- 866.5100
- Classification name
- Anti-Sm Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- SHELBY J HALL
- Address
- 7914 Via Callendo Carlsbad CA US 92009 92009
FDA Registration Numbers#
- 9680745
- 3015376545
- 1421346
- 2915274
- 3012348571
- 3039353646
- 2016706
- 3003935253
- 2026994
- 8043792
- 3007118747
- 3003268355
- 3004973408
- 3007361513
- 3010127294
- 2432235
- 9610566
Source Documents#
510(k) summary PDF not indicated by FDA
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| K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | Bio-Rad | 1998-12-22 |
| K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | Zeus Scientific, Inc. | 1998-11-18 |
| K980540 | SERAQUEST ANTI-SM | Quest Intl., Inc. | 1998-06-15 |
| K980811 | SERAQUEST ANTI-SM/RNP | Quest Intl., Inc. | 1998-05-12 |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | Orgentec | 1996-05-08 |