510(k) K000718
- Device
- CHROMOSTREAK
- Applicant
- NOVAMED LTD.
- 510(k) number
- K000718
- Product code
- JSN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-08-24
- Date received
- 2000-03-03
- Regulation
- 866.2390
- Classification name
- Culture Media, Propagating Transport
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- GERALD M SLUTZKY
- Address
- 28 Pierre Koenig St., Talpiot Industrial Area Jerusalem IL 93469 93469
FDA Registration Numbers#
- 8030124
- 2951280
- 1924669
Source Documents#
Other 510(k) Records For Product Code JSN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K962745 | ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) | Prepared Media Laboratory, Inc. | 1996-10-02 |
| K961755 | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | Proteins Intl., Inc. | 1996-05-17 |
| K961756 | CYTOQUANT VIRAL TRANSPORT MEDIUM | Proteins Intl., Inc. | 1996-05-17 |
| K896296 | INPOUCH-TV POUCH | Biomed Diagnostics, Inc. | 1990-01-29 |
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | Acumedia Manufacturers, Inc. | 1988-04-18 |
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | Diagnon Corp. | 1986-04-04 |
| K841208 | PROPAGATING TRANSPORT | Smith River Biologicals | 1984-04-05 |
| K833968 | 10B | Remel Co. | 1983-12-30 |
| K834065 | A3B | Remel Co. | 1983-12-27 |
| K831186 | RAPID NFT | Dms Laboratories | 1983-05-09 |
| K792201 | STREP CULTURETTE | Marion Health & Safety, Inc. | 1979-11-30 |
| K781304 | TRANSPORT MEDIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-14 |
Legacy Summary#
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FDA Review#
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