510(k) K983356
- Device
- C4
- Applicant
- ABBOTT LABORATORIES
- 510(k) number
- K983356
- Product code
- DBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-11-04
- Date received
- 1998-09-24
- Regulation
- 866.5240
- Classification name
- Complement C4, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LINDA MORRIS
- Address
- Dept. 09va Lc-2 1920 Hurd Dr. Irving TX US 75038 75038
FDA Registration Numbers#
- 2084025
- 3005094123
- 3006198300
- 3003795116
- 3009189893
- 1181121
- 9610099
- 9680746
- 2050012
- 9610806
- 3005333358
- 2432235
- 9610529
- 3012963943
- 2250051
- 1319808
- 3002809144
- 1000403749
- 2517506
- 3010097171
- 3003423869
- 3013059683
- 3019906
- 3004493545
- 3016438761
- 3002642396
- 2050010
- 3010825766
- 3012471076
- 9610126
- 1319681
- 3000308930
- 9614373
Source Documents#
Other 510(k) Records For Product Code DBI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100455 | SPAPLUS ANALYZER | The Binding Site | 2010-09-03 |
| K012359 | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | Roche Diagnostics Corp. | 2001-11-29 |
| K010325 | WAKO AUTOKIT C4 | Wako Chemicals USA, Inc. | 2001-06-25 |
| K000468 | RANDOX COMPLEMENT C4 | Randox Laboratories, Ltd. | 2000-03-27 |
| K994293 | DIMENSION C4 FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2000-03-01 |
| K981785 | C4 MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-12-20 |
| K993481 | K-ASSAY C4 | Kamiya Biomedical Co. | 1999-11-29 |
| K964300 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K964297 | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 |
| K962582 | OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-10-18 |
| K962198 | QUANTEX C4 | Instrumentation Laboratory CO | 1996-09-26 |
| K920010 | IL TEST COMPLEMENT 4 | Instrumentation Laboratory CO | 1992-03-13 |
| K911899 | RAICHEM SPIA C4 REAGENT | Reagents Applications, Inc. | 1991-05-09 |
| K892129 | EZ COMPLEMENT C4 | Diamedix Corp. | 1989-04-14 |
| K890564 | SPQ(TM) ANTIBODY REAGENT SET II FOR C4 | Atlantic Antibodies | 1989-02-17 |
Legacy Summary#
summary
FDA Review#
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