FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOLOGICAL/CHEMICAL INDICATOR
K Number: K772135
·
Decision Dec 8, 1977
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
19
Review Days
24
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
- BIOLOGICAL/CHEMICAL INDICATOR
- K Number
- K772135
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Amsco Co.
- Date Received
- November 14, 1977
- Decision Date
- December 8, 1977
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOJ), ordered by most recent decision date.
LF Process Indicator Tape for Steam Sterilization
FDA 510(k)
FDA Class 2
·General Hospital
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
FDA 510(k)
FDA Class 2
·General Hospital
DISINTEK PA Test Strips
FDA 510(k)
FDA Class 2
·General Hospital
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
FDA 510(k)
FDA Class 2
·General Hospital
VERIFY STEAM Integrating Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Green Card Bowie-Dick Test (BD115)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Amsco Co.
| K Number | Device Name | ||
|---|---|---|---|
| K912471 | EAGLE 3000 SDS | Jun 26, 1992 | Substantially Equivalent |
| K854922 | AMSCO POLARIS SL | Jan 24, 1986 | Substantially Equivalent |
| K833187 | HALL OSTEON | Oct 31, 1983 | Substantially Equivalent |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | Oct 19, 1983 | Substantially Equivalent |
| K832188 | HALL RECIPROCATOR | Aug 12, 1983 | Substantially Equivalent |
| K832187 | HALL OSCILLATOR | Aug 12, 1983 | Substantially Equivalent |
| K831086 | CEILING MOUNTED SUPPORT | Aug 12, 1983 | Substantially Equivalent |
| K832186 | HALL DRILL/REAMER | Aug 12, 1983 | Substantially Equivalent |
| K831309 | DELIVERY 4 TABLE | Jun 15, 1983 | Substantially Equivalent |
| K823360 | SURGICAL LIGHT | Dec 3, 1982 | Substantially Equivalent |