FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
K Number: K880477
·
Decision Mar 30, 1988
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
31
Applicant Total
15
Review Days
55
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Basic Information
- Device Name
- RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
- K Number
- K880477
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3820
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ampcor, Inc.
- Date Received
- February 4, 1988
- Decision Date
- March 30, 1988
- Product Code
- GMQ
- 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 |
|---|---|---|---|
| GMQ | Antigens, Nontreponemal, All | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMQ), ordered by most recent decision date.
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Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
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THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
FDA 510(k)
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Other Clearances by Ampcor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Jul 14, 1992 | Substantially Equivalent |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Jul 14, 1992 | Substantially Equivalent |
| K910438 | DIPSTICK SALMONELLA | Sep 13, 1991 | Substantially Equivalent |
| K893873 | SINGLE AND DUAL BAND DIPSTICK HCG TEST | Aug 21, 1989 | Substantially Equivalent |
| K890048 | QUIK-DOT TOXOPLASMOSIS | Jun 9, 1989 | Substantially Equivalent |
| K892146 | C REACTIVE PROTEIN LIQUID | Apr 14, 1989 | Substantially Equivalent |
| K892119 | QUIK-DOT C REACTIVE PROTEIN | Apr 14, 1989 | Substantially Equivalent |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | Jan 31, 1989 | Substantially Equivalent |
| K884750 | GROUP A STREP, BETA-STREP | Dec 22, 1988 | Substantially Equivalent |
| K880163 | PREGNANCY (HCG) CARD & LIQUID TEST | May 17, 1988 | Substantially Equivalent |