FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONCEP-7-BHCG
K Number: K880577
·
Decision Mar 15, 1988
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
49
Review Days
34
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Basic Information
- Device Name
- CONCEP-7-BHCG
- K Number
- K880577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Leeco Diagnostics, Inc.
- Date Received
- February 10, 1988
- Decision Date
- March 15, 1988
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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Other Clearances by Leeco Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Oct 31, 1989 | Substantially Equivalent |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Aug 15, 1989 | Substantially Equivalent |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Jun 16, 1989 | Substantially Equivalent |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Jun 16, 1989 | Substantially Equivalent |
| K883269 | PRL-QUANT | Sep 13, 1988 | Substantially Equivalent |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Feb 11, 1988 | Substantially Equivalent |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | Mar 10, 1987 | Substantially Equivalent |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | Feb 3, 1987 | Substantially Equivalent |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Jan 9, 1987 | Substantially Equivalent |
| K863933 | VIS-CUBE HCG (EIA) | Dec 15, 1986 | Substantially Equivalent |