FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HCG CONTROL KIT
K Number: K863744
·
Decision Nov 5, 1986
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
14
Review Days
42
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Basic Information
- Device Name
- HCG CONTROL KIT
- K Number
- K863744
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Monoclonal Antibodies, Inc.
- Date Received
- September 24, 1986
- Decision Date
- November 5, 1986
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 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 |
| 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 |
| K843284 | OVUSTICK SELF-TEST | Dec 11, 1984 | 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 |