510(k) K875159
- Device
- DETECTADOT SYSTEM 2000 CMV IGG TEST
- Applicant
- GULL LABORATORIES, INC.
- 510(k) number
- K875159
- Product code
- GQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-06
- Date received
- 1987-12-16
- Regulation
- 866.3175
- Classification name
- Antiserum, Cf, Cytomegalovirus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRED W RACHFORD
- Address
- 1011 E. 4800 S. Salt Lake City UT US 84117 84117
FDA Registration Numbers#
- 1318354
- 2032682
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GQI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Pyramid Biological Corp. | 1995-11-16 |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | Pyramid Biological Corp. | 1995-11-16 |
| K942171 | CMV EARLY ANTIGEN TEST | Neogenex | 1994-06-30 |
| K883102 | VIRGO (R) CMV-IGG ELISA | Electro-Nucleonics, Inc. | 1989-02-08 |
| K863488 | ENZYGNOST ANTI-CMV IGG TEST | Behring Diagnostics, Inc. | 1987-07-20 |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Microbiological Research Corp. | 1987-02-02 |
| K864420 | CMV MICROASSAY | Diamedix Corp. | 1987-02-02 |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | 1986-10-01 |
| K853989 | COR DOT CMV | Cordis Corp. | 1986-06-13 |
| K860493 | CYTOTECH CMV IGG EIA | Cytotech, Inc. | 1986-05-20 |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | Clinical Sciences, Inc. | 1986-02-05 |
| K843189 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | 1986-01-08 |
| K842529 | AMIZYME-CMV KIT | Amico Lab, Inc. | 1985-12-06 |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Amico Lab, Inc. | 1985-12-06 |
| K853137 | CMV TEST | Gull Laboratories, Inc. | 1985-11-14 |
Legacy Summary#
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FDA Review#
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