510(k) K812494
- Device
- IMMUNOGL. FRCT. OF RABBIT ANTISER.-HAPTO
- Applicant
- DAKO CORP.
- 510(k) number
- K812494
- Product code
- DAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-23
- Date received
- 1981-08-31
- Regulation
- 866.5460
- Classification name
- Haptoglobin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9614373
- 2517506
- 3016438761
- 1000403749
- 3005333358
- 3006198300
- 3004493545
- 3011989923
- 9680746
- 3000308930
- 1319808
- 2085064
- 3002809144
- 3012471076
- 3002642396
- 3005094123
- 9610126
- 3003795116
- 9610806
- 3019906
- 1181121
- 2084025
- 3012963943
- 2032839
- 2250051
- 2050012
- 9610529
- 3014325803
- 2050010
- 3003741796
- 2432235
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993480 | K-ASSAY HAPTOGLOBIN | Kamiya Biomedical Co. | 1999-11-24 |
| K972639 | TINA-QUANT HAPTOGLOBIN | Boehringer Mannheim Corp. | 1998-01-09 |
| K964301 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 |
| K963286 | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | Beckman Instruments, Inc. | 1996-10-07 |
| K952593 | N/T PROTEIN CONTROL SY/L, M AND H | Behring Diagnostics, Inc. | 1995-07-17 |
| K915829 | IL TEST(TM) HAPTOGLOBIN (HPT) | Instrumentation Laboratory CO | 1992-07-29 |
| K911898 | RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT | Reagents Applications, Inc. | 1991-05-08 |
| K890562 | SPQ(TM) ANTIBODY REAGENT SET II FOR HPT | Atlantic Antibodies | 1989-02-22 |
| K873866 | HAPTOGLOBIN | Unipath , Ltd. | 1987-10-20 |
| K872717 | QM300 HAPTOGLOBIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-21 |
| K864512 | IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTO | Cooper Biomedical, Inc. | 1987-02-13 |
| K850584 | SPQ TEST SYSTEM FOR HAPTOGLOBIN | Applications Lab | 1985-03-05 |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | Tago, Inc. | 1984-03-09 |
| K831957 | DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB | Kent Laboratories, Inc. | 1983-07-18 |
| K801433 | HAPTOGLOBIN NEPHELOMETRIC ASSAY | J.T. Baker Chemical Co. | 1980-07-08 |
Legacy Summary#
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FDA Review#
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