FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OVUSTICK SELF-TEST
K Number: K843284
·
Decision Dec 11, 1984
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
14
Review Days
113
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Basic Information
- Device Name
- OVUSTICK SELF-TEST
- K Number
- K843284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Monoclonal Antibodies, Inc.
- Date Received
- August 20, 1984
- Decision Date
- December 11, 1984
- Product Code
- CEP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Monoclonal Antibodies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874863 | RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) | Feb 16, 1988 | Substantially Equivalent |
| K871726 | OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) | Jul 27, 1987 | Substantially Equivalent |
| K863744 | HCG CONTROL KIT | Nov 5, 1986 | Substantially Equivalent |
| K860924 | RAMP PROGESTURINE PDG ASSAY--48 TEST KIT | Jul 2, 1986 | Substantially Equivalent |
| K854611 | RAMP URINE HCG ASSAY | Dec 30, 1985 | Substantially Equivalent |
| K850730 | MODEL SERUM HCG ASSAY | Apr 2, 1985 | Substantially Equivalent |
| K850480 | OVU STICK SELF-TEST -MODIFICATION | Mar 5, 1985 | Substantially Equivalent |
| K840738 | PLUS URINE HCG ASSAY | Apr 19, 1984 | Substantially Equivalent |
| K840412 | OVU STICK URINE HLH KIT | Apr 13, 1984 | Substantially Equivalent |
| K833504 | PREGNASTICK URINE HCG KIT | Jan 9, 1984 | Substantially Equivalent |