FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROPPER SUPER SERACULT(R)
K Number: K921798
·
Decision Oct 5, 1992
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
25
Review Days
174
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
- PROPPER SUPER SERACULT(R)
- K Number
- K921798
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Propper Mfg. Co., Inc.
- Date Received
- April 14, 1992
- Decision Date
- October 5, 1992
- Product Code
- KHE
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KHE | Reagent, Occult Blood | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHE), ordered by most recent decision date.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
InSure ONE
FDA 510(k)
FDA Class 2
·Hematology
hema-screen SPECIFIC Gold
FDA 510(k)
FDA Class 2
·Hematology
Wondfo One Step Fecal Occult Blood (FOB) Test
FDA 510(k)
FDA Class 2
·Hematology
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
FDA 510(k)
FDA Class 2
·Hematology
OC-Light S FIT
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Propper Mfg. Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K111453 | STEAM DOT BLU PROCESS INDICATOR | Apr 5, 2012 | Substantially Equivalent |
| K102894 | CLASSIX CHEMICAL STERILIZATION INDICATOR | May 25, 2011 | Substantially Equivalent |
| K082620 | ONCE-A-DAY VERTOS TEST PACK | Jul 8, 2009 | Substantially Equivalent |
| K031152 | PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) | Aug 17, 2004 | Substantially Equivalent |
| K991618 | BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR | Jan 24, 2001 | Substantially Equivalent |
| K991276 | PASS/FAIL CHALLENGE PACK | Jul 12, 1999 | Substantially Equivalent |
| K973585 | PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR | Nov 6, 1998 | Substantially Equivalent |
| K972747 | BI-O.K. EO GAS BIOLOGICAL TEST-PAK (269305,269310,269320) | Jan 9, 1998 | Substantially Equivalent |
| K961156 | ONCE-A-DAY BOWIE AND DICK TEST PACK. | Apr 1, 1997 | Substantially Equivalent |
| K915804 | PROPPER LARYNGOSCOPE BLADES W FIBER OPTIC ILLUM. | Mar 20, 1992 | Substantially Equivalent |