GERM TUBE SOLUTION
FDA 510(k) clearance K884720 · decided 1989-06-02
Clearance details
- K-number
- K884720
- Device name
- GERM TUBE SOLUTION
- Applicant
- Remel Co.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-10
- Decision date
- 1989-06-02
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- JXC
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Lenexa, KS, 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 |
|---|---|---|
| CHROMAGAR CANDIDA (K960075) | Hardy Diagnostics | 1996-08-02 |
| ALBICANS SURE (K913426) | Jrga Diagnostics | 1992-04-22 |
| C. ALBICANS SCREEN (K891476) | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 |
| SOC SLIDE CULTURE SYSTEM (K882371) | The Cancer Center AT Wadley Institutes | 1988-07-18 |
| QUANTUM II YEAST IDENT. SYSTEM (K832406) | Abbott Laboratories | 1983-09-26 |
Recalls involving this device
No recalls on record reference this clearance.