FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDS O.S. MONO
K Number: K902510
·
Decision Jul 16, 1990
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
29
Review Days
41
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CARDS O.S. MONO
- K Number
- K902510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Pacific Biotech, Inc.
- Date Received
- June 5, 1990
- Decision Date
- July 16, 1990
- Product Code
- KTN
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTN), ordered by most recent decision date.
OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
FDA 510(k)
FDA Class 2
·Immunology
ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)
FDA 510(k)
FDA Class 2
·Immunology
BIORAPID MONONUCLEOSIS
FDA 510(k)
FDA Class 2
·Immunology
COLOR-MONOGEN
FDA 510(k)
FDA Class 2
·Immunology
DRYSPOT INFECTIOUS MONONUCLEOSIS KIT
FDA 510(k)
FDA Class 2
·Immunology
CLEARVIEW IM
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Pacific Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | Dec 2, 1993 | Substantially Equivalent |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | Mar 6, 1990 | Substantially Equivalent |
| K896221 | CARDS O.S.(TM) STREP A | Dec 13, 1989 | Substantially Equivalent |
| K895390 | CARDS O.S. (TM) HCG-URINE | Nov 13, 1989 | Substantially Equivalent |
| K891770 | HCG IRMA II | May 24, 1989 | Substantially Equivalent |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | Jan 13, 1989 | Substantially Equivalent |
| K883742 | MODIFIED TSH IRMA KIT | Jan 3, 1989 | Substantially Equivalent |
| K884007 | CARDS(TM) MONO | Nov 18, 1988 | Substantially Equivalent |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | Oct 12, 1988 | Substantially Equivalent |
| K883639 | MODIFIED HCG IRMA KIT | Oct 6, 1988 | Substantially Equivalent |