FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
K Number: K900625
·
Decision Feb 26, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
68
Review Days
18
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Basic Information
- Device Name
- MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET
- K Number
- K900625
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- February 8, 1990
- Decision Date
- February 26, 1990
- Product Code
- KTN
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
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|---|---|---|---|
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| 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 |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |