FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TRANSPORT MEDIA
K Number: K781304
·
Decision Aug 14, 1978
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
12
Applicant Total
632
Review Days
18
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Basic Information
- Device Name
- TRANSPORT MEDIA
- K Number
- K781304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- July 27, 1978
- Decision Date
- August 14, 1978
- Product Code
- JSN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSN | Culture Media, Propagating Transport | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSN), ordered by most recent decision date.
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INPOUCH-TV POUCH
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AMIES TRANSPORT MEDIUM W/O CHARCOAL
FDA 510(k)
FDA Class 1
·Microbiology
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| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
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| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |