FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K Number: K812272
·
Decision Sep 8, 1981
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
37
Review Days
26
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
- CASTLE TEC-TEST BIOLOGICAL INDICATOR
- K Number
- K812272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- August 13, 1981
- Decision Date
- September 8, 1981
- 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 Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
| K854855 | PROOF ALGINATE IMPRESSION MATERIAL | Jan 30, 1986 | Substantially Equivalent |
| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | Oct 25, 1984 | Substantially Equivalent |
| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | Jul 18, 1984 | Substantially Equivalent |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Jul 13, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |