FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K Number: K875203
·
Decision Aug 30, 1988
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
26
Applicant Total
253
Review Days
256
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Basic Information
- Device Name
- DU PONT EBNA-IGG ANTIBODY ELISA KIT
- K Number
- K875203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Date Received
- December 18, 1987
- Decision Date
- August 30, 1988
- Product Code
- LLM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| LLM | Test, Antigen, Nuclear, Epstein-Barr Virus | FDA class 1 | Microbiology |
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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 |