FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXSURE OBT
K Number: K961062
·
Decision Nov 6, 1996
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
42
Review Days
233
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
- FLEXSURE OBT
- K Number
- K961062
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- March 18, 1996
- Decision Date
- November 6, 1996
- 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 Smithkline Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960183 | FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS) | Jun 7, 1996 | Substantially Equivalent |
| K934863 | FLEXSURE HP | May 18, 1994 | Substantially Equivalent |
| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent |
| K875131 | (SKD) CHOLESTEROL TEST KIT | Mar 1, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | Jul 24, 1985 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | May 24, 1982 | Substantially Equivalent |