FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOVAPATH SPECIMEN COLLECTION KIT
K Number: K884342
·
Decision Nov 3, 1988
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
62
Applicant Total
319
Review Days
20
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
- NOVAPATH SPECIMEN COLLECTION KIT
- K Number
- K884342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2900
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Rad
- Date Received
- October 14, 1988
- Decision Date
- November 3, 1988
- 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 Bio-Rad
| K Number | Device Name | ||
|---|---|---|---|
| K171061 | MRSASelect II | Dec 28, 2017 | Substantially Equivalent |
| K122187 | VRESELECT CULTURE MEDIUM | Nov 6, 2012 | Substantially Equivalent |
| K103684 | VRESELECT CULTURE MEDIUM | Oct 21, 2011 | Substantially Equivalent |
| K093678 | PLATELIA ASPERGILLUS EIA MODEL 62793 | Jan 13, 2011 | Substantially Equivalent |
| K100589 | MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS | Oct 29, 2010 | Substantially Equivalent |
| K081362 | PLATELIA LYME IGM | Jun 26, 2008 | Substantially Equivalent |
| K081212 | MRSASELECT - EXTENDED INCUBATION | Jun 13, 2008 | Substantially Equivalent |
| K080012 | PLATELIA LYME IGG ASSAY | May 8, 2008 | Substantially Equivalent |
| K070361 | MRSASELECT | Sep 13, 2007 | Substantially Equivalent |
| K060641 | PLATELIA ASPERGILLUS EIA, MODEL 62793 | Jun 2, 2006 | Substantially Equivalent |