RIM-HAEMOPHILUS 1 & 2
FDA 510(k) clearance K832051 · decided 1983-08-12
Clearance details
- K-number
- K832051
- Device name
- RIM-HAEMOPHILUS 1 & 2
- Applicant
- Austin Biological Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1983-06-24
- Decision date
- 1983-08-12
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JST
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM (K962423) | Becton Dickinson Microbiology Systems | 1996-08-02 |
| API 50 CHB (CULTURE MEDIA) (K854732) | Dms Products, Inc. | 1986-03-04 |
| SYNTHETIC BROTH A.O.A.C. (K841661) | Oxoid U.S.A., Inc. | 1984-05-11 |
| RIM-HAEMOPHILUS 2 (K832239) | Austin Biological Laboratories | 1983-08-12 |
| STREPTOCOCUS ID PLATE (K831349) | Granite Diagnostics, Inc. | 1983-05-16 |
Recalls involving this device
No recalls on record reference this clearance.