FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMUNEX CRP
K Number: K812881
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
69
Applicant Total
65
Review Days
12
Basic Information
- Device Name
- IMMUNEX CRP
- K Number
- K812881
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5270
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- ARMKEL, LLC.
- Date Received
- October 14, 1981
- Decision Date
- October 26, 1981
- Product Code
- DCN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| DCN | System, Test, C-Reactive Protein | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DCN), ordered by most recent decision date.
CardioPhase® hsCRP
FDA 510(k)
FDA Class 2
·Immunology
RCRP Flex reagent cartridge
FDA 510(k)
FDA Class 2
·Immunology
Tina-quant C-Reactive Protein IV
FDA 510(k)
FDA Class 2
·Immunology
Optilite High Sensitivity C-Reactive Protein Kit
FDA 510(k)
FDA Class 2
·Immunology
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
FDA 510(k)
FDA Class 2
·Immunology
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by ARMKEL, LLC.
| K Number | Device Name | ||
|---|---|---|---|
| K030258 | FIRST RESPONSE PREGNANCY TEST | Feb 25, 2003 | Substantially Equivalent |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Dec 16, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Mar 3, 1997 | Substantially Equivalent |
| K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM | Feb 24, 1997 | Substantially Equivalent |
| K963645 | HERPES GROUP IGG ELISA TEST SYSTEM | Feb 4, 1997 | Substantially Equivalent |