FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
KULTSURE (CATALOGUE NO. M200)
K Number: K860655
·
Decision Mar 6, 1986
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
15
Review Days
13
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
- KULTSURE (CATALOGUE NO. M200)
- K Number
- K860655
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ncs Diagnostics, Inc.
- Date Received
- February 21, 1986
- Decision Date
- March 6, 1986
- Product Code
- LIO
- 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 |
|---|---|---|---|
| LIO | Device, Specimen Collection | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LIO), ordered by most recent decision date.
ARX Liquid Amies Collection & Transport System
FDA 510(k)
FDA Class 1
·Microbiology
PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
TRANSPORT CULTURE MEDIUM DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICE
FDA 510(k)
FDA Class 1
·Microbiology
VIROCULT, MODEL MW950
FDA 510(k)
FDA Class 1
·Microbiology
COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USE
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Ncs Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943498 | KULTSURE STARSWAB (M210), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K943499 | KULTSURE STARSWAB(M240), MODIFICATION | Nov 30, 1994 | Substantially Equivalent |
| K882811 | STREPSLIDE | Oct 25, 1988 | Substantially Equivalent |
| K881209 | ASO SLIDE TEST | Apr 12, 1988 | Substantially Equivalent |
| K874019 | STAPHSLIDE | Oct 28, 1987 | Substantially Equivalent |
| K871404 | KULTSURE | Apr 21, 1987 | Substantially Equivalent |
| K870231 | KULTSURE | Feb 4, 1987 | Substantially Equivalent |
| K860178 | KULTSURE (CULTURE TRANSPORT) | Apr 4, 1986 | Substantially Equivalent |
| K860657 | KULTSURE (CATALOGUE NO. M240) | Mar 4, 1986 | Substantially Equivalent |
| K860656 | KULTSURE (CATALOGUE NO. M210) | Mar 4, 1986 | Substantially Equivalent |