FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SORVALL EMBEDDING MEDIUM
K Number: K760602
·
Decision Sep 21, 1976
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
10
Applicant Total
253
Review Days
14
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Basic Information
- Device Name
- SORVALL EMBEDDING MEDIUM
- K Number
- K760602
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Date Received
- September 7, 1976
- Decision Date
- September 21, 1976
- Product Code
- KEO
- Advisory Committee
- Pathology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KEO | Formulations, Paraffin, All | FDA class 1 | Pathology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KEO), ordered by most recent decision date.
TISSUE EMBEDDING MEDIUM
FDA 510(k)
FDA Class 1
·Pathology
MICRO THIN* PARAFFIN
FDA 510(k)
FDA Class 1
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HISTOLOGY PARAFFIN
FDA 510(k)
FDA Class 1
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BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.
FDA 510(k)
FDA Class 1
·Pathology
PARAPLAST EXTRA TISSUE EMBEDDING MED.
FDA 510(k)
FDA Class 1
·Pathology
TECHNICON PARACUT
FDA 510(k)
FDA Class 1
·Pathology
Other Clearances by E.I. Dupont DE Nemours & Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | Jul 24, 1996 | Substantially Equivalent |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | Sep 6, 1995 | Substantially Equivalent |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | Sep 6, 1995 | Substantially Equivalent |
| K951441 | DUPONT ACA DIGOXIN (DGN A) METHOD | Jun 1, 1995 | Substantially Equivalent |
| K950137 | URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 13, 1995 | Substantially Equivalent |
| K950136 | URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 5, 1995 | Substantially Equivalent |
| K950181 | URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE | Apr 5, 1995 | Substantially Equivalent |
| K950135 | URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE | Mar 30, 1995 | Substantially Equivalent |
| K950182 | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | Mar 21, 1995 | Substantially Equivalent |
| K950134 | URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE | Mar 21, 1995 | Substantially Equivalent |