GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
FDA 510(k) clearance K974572 · decided 1998-09-24
Clearance details
- K-number
- K974572
- Device name
- GEN-PROBE ACCUPROBE GROUP B STREPTOCOCCUS CULTURE IDENTIFICATION TEST 2820
- Applicant
- Chugai Pharmaceuticals Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-05
- Decision date
- 1998-09-24
- Days to decision
- 293 days
- Clearance type
- Traditional
- Product code
- MDK
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST (K924715) | Gen-Probe, Inc. | 1994-03-11 |
| ACCUPACE GROUP A STREPTOCOCCUS ID TEST (K915852) | Gen-Probe, Inc. | 1992-04-02 |
| ACCUPROBE STREPTOCOCCUS PYOGENES CULTURE CONFIRM. (K904268) | Gen-Probe, Inc. | 1990-11-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820. recall (Z-1436-2011) | Gen-Probe Inc | 2011-03-10 |
| Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch N recall (Z-0145-2008) | Gen-Probe Inc | 2007-12-19 |