510(k) K894617
- Device
- OLYMPUS PK-TP SYSTEM REACTIVE CONTROL
- Applicant
- SCHIFF & CO.
- 510(k) number
- K894617
- Product code
- GMI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-31
- Date received
- 1989-07-20
- Regulation
- 866.3135
- Classification name
- Antigen, Cf And / Or Id, Coccidioides Immitis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT SCHIFF
- Address
- 1129 Bloomfield Ave. West Cadwell NJ US 07006 07006
FDA Registration Numbers#
- 1524213
- 1627497
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GMI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K812190 | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-31 |
| K812185 | FUNGAL IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-25 |
| K802129 | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | Nolan Biological Laboratories, Inc. | 1980-09-26 |
| K792716 | CANDIDA ALBICANS, ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-24 |
| K792713 | CANDIDA ALBICANS, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-23 |
| K792682 | COCCIDIOIDES IMMITIS, ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-17 |
| K792689 | COCCIDIOIDES IMMITIS, ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-17 |
| K791383 | CANDIDA IMMUNODIFFUSION KIT #CA1001 | Immuno-Mycologics, Inc. | 1979-08-16 |
| K791389 | COCCIDIOIDES ANTIGEN #CF10023X | Immuno-Mycologics, Inc. | 1979-08-16 |
| K770527 | CANDIDA IMMUNODIFFUSION KIT | I M, Inc. | 1978-03-17 |
Legacy Summary#
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FDA Review#
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