FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RHEUMATOID FACTOR REFERENCE PREPARA.
K Number: K821941
·
Decision Aug 27, 1982
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
143
Applicant Total
68
Review Days
59
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Basic Information
- Device Name
- RHEUMATOID FACTOR REFERENCE PREPARA.
- K Number
- K821941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- June 29, 1982
- Decision Date
- August 27, 1982
- Product Code
- DHR
- 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 |
|---|---|---|---|
| DHR | System, Test, Rheumatoid Factor | FDA class 2 | Immunology |
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|---|---|---|---|
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| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |