510(k) K884720
- Device
- GERM TUBE SOLUTION
- Applicant
- REMEL CO.
- 510(k) number
- K884720
- Product code
- JXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-02
- Date received
- 1988-11-10
- Regulation
- 866.2660
- Classification name
- Kit, Screening, Yeast
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRENDA TEPLY
- Address
- 12076 Santa Fe Dr. Lenexa KS US 66215 66215
FDA Registration Numbers#
- 3003750284
- 1924669
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JXC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960075 | CHROMAGAR CANDIDA | Hardy Diagnostics | 1996-08-02 |
| K913426 | ALBICANS SURE | Jrga Diagnostics | 1992-04-22 |
| K891476 | C. ALBICANS SCREEN | Carr-Scarborough Microbiologicals, Inc. | 1989-04-12 |
| K882371 | SOC SLIDE CULTURE SYSTEM | The Cancer Center AT Wadley Institutes | 1988-07-18 |
| K832406 | QUANTUM II YEAST IDENT. SYSTEM | Abbott Laboratories | 1983-09-26 |
Legacy Summary#
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FDA Review#
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