FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K Number: K962843
·
Decision Sep 18, 1996
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
11
Review Days
58
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
- K Number
- K962843
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Starplex Scientific, Inc.
- Date Received
- July 22, 1996
- Decision Date
- September 18, 1996
- Product Code
- JSM
- 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 |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSM), ordered by most recent decision date.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
FDA 510(k)
FDA Class 1
·Microbiology
Babio® Virus Transport Kit (Non-inactivating)
FDA 510(k)
FDA Class 1
·Microbiology
AllTest Viral Transport Medium
FDA 510(k)
FDA Class 1
·Microbiology
UriSponge
FDA 510(k)
FDA Class 1
·Microbiology
Ensol EnTM Specimen Collection and Transport System
FDA 510(k)
FDA Class 1
·Microbiology
OmniTrans Transport System
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Starplex Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K032246 | MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | Aug 13, 2003 | Substantially Equivalent |
| K022388 | STARTOX DRUG OF ABUSE SCREENING TEST (4) | Feb 27, 2003 | Substantially Equivalent |
| K021006 | STARTOX DRUG OF ABUSE SCREENING TEST | Jun 10, 2002 | Substantially Equivalent |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Apr 3, 1996 | Substantially Equivalent |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Feb 16, 1995 | Substantially Equivalent |
| K924361 | VACUPLUS TUBES WITH GREEN STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924362 | VACUPLUS TUBES WITH LAVANDER STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924364 | VACUPLUS TUBES WITH GREY STOPPERS | Mar 1, 1993 | Substantially Equivalent |
| K924363 | VACUPLUS(R) STAR-SEP(TM) | Feb 8, 1993 | Substantially Equivalent |
| K924365 | VACUPLUS TUBES WITH BRICK RED STOPPERS | Dec 28, 1992 | Substantially Equivalent |