510(k) K850591
- Device
- FIAX TOXO-M ANTIBODIES TEST KIT
- Applicant
- INTL. DIAGNOSTIC TECHNOLOGY
- 510(k) number
- K850591
- Product code
- GLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-30
- Date received
- 1985-02-14
- Regulation
- 866.3780
- Classification name
- Antigens, If, Toxoplasma Gondii
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUFF SELF
- Address
- 2050 Concourse Dr. San Jose CA US 95131 95131
FDA Registration Numbers#
- 2029372
- 1181055
- 2242436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924882 | TOXOPLASMA IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1993-03-23 |
| K880007 | TOXO IGM TEST | Gull Laboratories, Inc. | 1988-03-17 |
| K844287 | ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII | Apple Diagnostic Products | 1985-01-07 |
| K842664 | ANTI-TOXOPLASMA GONDII KIT | Amico Lab, Inc. | 1984-08-28 |
| K832900 | IMMUNOENZYME TEST SYS-DETECT-IGM ANTI | Bionetic Laboratory Products | 1983-11-14 |
| K830869 | POLYCHACO INDIRECT IMMUNOFLUORESCENCE | Parasitic Disease Consultants | 1983-08-11 |
| K811562 | TOXOPLASMOSIS TEST KIT | Immuno-Diagnostic Products, Inc. | 1981-07-16 |
| K803134 | TOXOPLASMA GONDII SEROLOGICAL REAGENTS | Microbiological Research Corp. | 1981-01-29 |
| K801720 | TOXO BIO-BEAD TITRATION KIT | Litton Bionetics | 1980-09-16 |
| K791618 | TORCH BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
| K791611 | TOXO BIO-BEAD SCREEN KIT | Litton Bionetics | 1979-11-13 |
| K791571 | TOXOPLASMA ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1979-09-24 |
| K790464 | FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO | Intl. Diagnostic Technology | 1979-06-13 |
| K790360 | QUANTAZYME TOXOPLASMA | Bio-Rad | 1979-05-22 |
| K781549 | TOXELISA TEST KIT | Microbiological Assoc. | 1978-12-07 |
Legacy Summary#
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FDA Review#
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