510(k) K915852
- Device
- ACCUPACE GROUP A STREPTOCOCCUS ID TEST
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K915852
- Product code
- MDK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-04-02
- Date received
- 1991-12-27
- Regulation
- 866.3740
- Classification name
- Dna-probe, Reagents, Streptococcal
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RUBEN CHIREZ
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
Source Documents#
Other 510(k) Records For Product Code MDK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974572 | GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820 | Chugai Pharmaceuticals Co., Ltd. | 1998-09-24 |
| K924715 | GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST | Gen-Probe, Inc. | 1994-03-11 |
| K904268 | ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. | Gen-Probe, Inc. | 1990-11-13 |
Legacy Summary#
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FDA Review#
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