510(k) K896494
- Device
- ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K896494
- Product code
- LQF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-23
- Date received
- 1989-11-13
- Regulation
- 866.3370
- Classification name
- Dna-reagents, Mycobacterium Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUNI, PHD
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K921435 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | Gen-Probe, Inc. | 1992-07-23 |
| K904463 | ACCUPROBE MYCOBACTERIUM KANSASII CULT CONFIRM TEST | Gen-Probe, Inc. | 1990-11-13 |
| K897077 | ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE | Gen-Probe, Inc. | 1990-08-23 |
| K897078 | ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE | Gen-Probe, Inc. | 1990-05-02 |
| K896492 | ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST | Gen-Probe, Inc. | 1990-04-16 |
| K896493 | ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST | Gen-Probe, Inc. | 1990-04-11 |
| K900202 | SNAP MYCOBACTERIA AVIUM COMPLEX | Syngene, Inc. | 1990-04-03 |
| K900292 | SNAP M. TUBERCULOSIS COMPLEX | Syngene, Inc. | 1990-04-03 |
| K890089 | RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE | Gen-Probe, Inc. | 1989-03-13 |
| K871795 | RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. | Gen-Probe, Inc. | 1987-07-30 |
| K864597 | GEN-PROBE RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIA | Gen-Probe, Inc. | 1987-04-20 |
| K862613 | RAPID IDENT. TEST FOR MYCOBACTERIUM AVIUM COMPLEX | Gen-Probe, Inc. | 1986-11-10 |
| K862614 | RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX | Gen-Probe, Inc. | 1986-11-10 |
| K860782 | GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM | Gen-Probe, Inc. | 1986-07-02 |
Legacy Summary#
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FDA Review#
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