510(k) K832069
- Device
- TOXO IPA KIT IAN INDIRECT FLUORESCENT
- Applicant
- BIONETIC LABORATORY PRODUCTS
- 510(k) number
- K832069
- Product code
- LJK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-26
- Date received
- 1983-06-27
- Regulation
- 866.3780
- Classification name
- Antisera, If, Toxoplasma Gondii
- Medical specialty
- Microbiology
- 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#
- 2032682
- 3007088335
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LJK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974261 | ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-12-11 |
| K911771 | ARD(TM) ANTIMICROBIAL REMOVAL DEVICE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-07-01 |
| K861122 | THE GOLDEN QUAD TEST (TOXO) | Microbiological Research Corp. | 1987-02-02 |
| K861460 | SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101 | Widran Urological Group, Ltd. | 1986-05-02 |
| K822605 | TOXOPLASMA GONDII ANTIBODY IGG | Immulok, Inc. | 1982-10-27 |
Legacy Summary#
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FDA Review#
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