FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
K Number: K926364
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
49
Review Days
829
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
- ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X
- K Number
- K926364
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Health Care, Ltd.
- Date Received
- December 22, 1992
- Decision Date
- March 31, 1995
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRC), ordered by most recent decision date.
Celerity 5 HP Biological Indicator (LCB052)
FDA 510(k)
FDA Class 2
·General Hospital
Celerity 20 HP Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Terragene® Bionova® BT20 Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
FDA 510(k)
FDA Class 2
·General Hospital
Celerity Incubator
FDA 510(k)
FDA Class 2
·General Hospital
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by 3M Health Care, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K953904 | SARNS 9000 UNIVERSAL ROLLER PUMP | Apr 19, 1996 | Substantially Equivalent |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | Mar 6, 1995 | Substantially Equivalent |
| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | Dec 2, 1994 | Substantially Equivalent |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | Feb 10, 1994 | Substantially Equivalent |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | Dec 27, 1993 | Substantially Equivalent |
| K932446 | INJECTION SITE | Nov 29, 1993 | Substantially Equivalent |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | Nov 10, 1993 | Substantially Equivalent |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | Oct 25, 1993 | Substantially Equivalent |
| K933005 | AVI MODEL 600 SYRINGE PUMP | Oct 25, 1993 | Substantially Equivalent |