FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
K Number: K844369
·
Decision Jan 4, 1985
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
25
Review Days
52
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
- BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO
- K Number
- K844369
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Precision Dynamics Corp.
- Date Received
- November 13, 1984
- Decision Date
- January 4, 1985
- 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 Precision Dynamics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Jun 3, 2002 | Substantially Equivalent |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Mar 22, 2000 | Substantially Equivalent |
| K994263 | SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 | Jan 24, 2000 | Substantially Equivalent |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Apr 6, 1999 | Substantially Equivalent |
| K884357 | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Nov 1, 1988 | Substantially Equivalent |
| K882580 | MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE | Jul 8, 1988 | Substantially Equivalent |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Jan 20, 1988 | Unknown |
| K873369 | SECURLINE FRANSEENE NEEDLE | Oct 20, 1987 | Substantially Equivalent |
| K872507 | PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II | Jul 9, 1987 | Substantially Equivalent |
| K863164 | AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA | Aug 27, 1986 | Substantially Equivalent |