FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
K Number: K032246
·
Decision Aug 13, 2003
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
11
Review Days
22
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Basic Information
- Device Name
- MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
- K Number
- K032246
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Starplex Scientific, Inc.
- Date Received
- July 22, 2003
- Decision Date
- August 13, 2003
- 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 |
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Other Clearances by Starplex Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K962843 | MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM | Sep 18, 1996 | 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 |