FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCCULT SENSITIVE TEST
K Number: K880499
·
Decision May 23, 1988
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
96
Applicant Total
42
Review Days
108
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Basic Information
- Device Name
- HEMOCCULT SENSITIVE TEST
- K Number
- K880499
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- February 5, 1988
- Decision Date
- May 23, 1988
- 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 |
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Other Clearances by Smithkline Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961062 | FLEXSURE OBT | Nov 6, 1996 | Substantially Equivalent |
| 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 |
| 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 |