510(k) K883002
- Device
- QM300 PREALBUMIN ANTIBODY PACK
- Applicant
- KALLESTAD DIAG, A DIV. OF ERBAMONT, INC.
- 510(k) number
- K883002
- Product code
- JZJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-22
- Date received
- 1988-07-18
- Regulation
- 866.5060
- Classification name
- Prealbumin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAN NEBELSICK
- Address
- 2000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2432235
- 2085064
- 3012963943
- 3014325803
- 1319681
- 3014607865
- 3016438761
- 3013059683
- 2050010
- 3012471076
- 2050012
- 3019906
- 3002642396
- 2250051
- 3002809144
- 3000148879
- 1181121
- 9610806
- 9610099
- 1000403749
- 1319808
- 3003423869
- 3004493545
- 9610126
- 3003741796
- 2517506
- 3009189893
- 3005094123
- 3000308930
- 3017379203
- 2084025
- 9614373
- 3005333358
- 8040374
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JZJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000661 | RANDOX PREALBUMIN | Randox Laboratories, Ltd. | 2000-04-13 |
| K972638 | TINA-QUANT PREALBUMIN | Boehringer Mannheim Corp. | 1998-01-09 |
| K951966 | HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | 1995-06-01 |
| K913672 | PREALBUMIN IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1991-12-20 |
| K884297 | SPQ(TM) TEST SYSTEM FOR PREALBUMIN | Atlantic Antibodies | 1988-11-02 |
| K884298 | SPQ(TM) TEST SYSTEM FOR MICROALBUMIN | Atlantic Antibodies | 1988-11-02 |
| K850686 | ANTISERUM TO HUMAN PREALBUMIN | Kent Laboratories, Inc. | 1985-11-01 |
| K851912 | LASER PREALBUMIN TEST | Behring Diagnostics, Inc. | 1985-06-21 |
| K821135 | PREALBUMIN ENZYME IMMUNOASSAY | Abbott Laboratories | 1983-05-05 |
| K772329 | LAS-R HUMAN PREALBUMIN TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 |
Legacy Summary#
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FDA Review#
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