Culture Media, Propagating Transport
Culture Media, Propagating Transport is a microbiological transport medium designed to sustain and actively propagate microorganisms present in clinical specimens during transit to a testing laboratory, helping ensure sufficient organism recovery. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JSN, regulated under 21 CFR 866.2390, and falls within the Microbiology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- JSN
- Device Class
- FDA class 1
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K000718 | CHROMOSTREAK | Aug 24, 2000 | Substantially Equivalent | Novamed , Ltd. |
| K962745 | ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000) | Oct 02, 1996 | Substantially Equivalent | Prepared Media Laboratory, Inc. |
| K961756 | CYTOQUANT VIRAL TRANSPORT MEDIUM | May 17, 1996 | Substantially Equivalent | Proteins Intl., Inc. |
| K961755 | CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM | May 17, 1996 | Substantially Equivalent | Proteins Intl., Inc. |
| K896296 | INPOUCH-TV POUCH | Jan 29, 1990 | Substantially Equivalent | Biomed Diagnostics, Inc. |
| K881579 | AMIES TRANSPORT MEDIUM W/O CHARCOAL | Apr 18, 1988 | Substantially Equivalent | Acumedia Manufacturers, Inc. |
| K860967 | VIRTRAN VIRAL TRANSPORTER (MODIFIED) | Apr 04, 1986 | Substantially Equivalent | Diagnon Corp. |
| K841208 | PROPAGATING TRANSPORT | Apr 05, 1984 | Substantially Equivalent | Smith River Biologicals |
| K833968 | 10B | Dec 30, 1983 | Substantially Equivalent | Remel Co. |
| K834065 | A3B | Dec 27, 1983 | Substantially Equivalent | Remel Co. |
| K831186 | RAPID NFT | May 09, 1983 | Substantially Equivalent | Dms Laboratories |
| K792201 | STREP CULTURETTE | Nov 30, 1979 | Substantially Equivalent | Marion Health & Safety, Inc. |
| K781304 | TRANSPORT MEDIA | Aug 14, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.