CHROMOSTREAK
FDA 510(k) clearance K000718 · decided 2000-08-24
Clearance details
- K-number
- K000718
- Device name
- CHROMOSTREAK
- Applicant
- Novamed , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-03
- Decision date
- 2000-08-24
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- JSN
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Jerusalem, IL
- 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 |
|---|---|---|
| ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) (K962745) | Prepared Media Laboratory, Inc. | 1996-10-02 |
| CYTOQUANT VIRAL TRANSPORT MEDIUM (K961756) | Proteins Intl., Inc. | 1996-05-17 |
| CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM (K961755) | Proteins Intl., Inc. | 1996-05-17 |
| INPOUCH-TV POUCH (K896296) | Biomed Diagnostics, Inc. | 1990-01-29 |
| AMIES TRANSPORT MEDIUM W/O CHARCOAL (K881579) | Acumedia Manufacturers, Inc. | 1988-04-18 |
| VIRTRAN VIRAL TRANSPORTER (MODIFIED) (K860967) | Diagnon Corp. | 1986-04-04 |
| PROPAGATING TRANSPORT (K841208) | Smith River Biologicals | 1984-04-05 |
| 10B (K833968) | Remel Co. | 1983-12-30 |
| A3B (K834065) | Remel Co. | 1983-12-27 |
| RAPID NFT (K831186) | Dms Laboratories | 1983-05-09 |
| STREP CULTURETTE (K792201) | Marion Health & Safety, Inc. | 1979-11-30 |
| TRANSPORT MEDIA (K781304) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 |
Recalls involving this device
No recalls on record reference this clearance.