FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISCOVER(R)
K Number: K882232
·
Decision Oct 25, 1988
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
20
Review Days
151
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Basic Information
- Device Name
- DISCOVER(R)
- K Number
- K882232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Carter Products
- Date Received
- May 27, 1988
- Decision Date
- October 25, 1988
- Product Code
- LCX
- 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 |
|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | FDA class 2 | Clinical Chemistry |
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Other Clearances by Carter Products
| K Number | Device Name | ||
|---|---|---|---|
| K955672 | TROJAN POLYURETHANE CONDOM (MODIFICATION) | Aug 29, 1996 | Substantially Equivalent |
| K942697 | TROJAN POLYURETHANE CONDOM | Jun 22, 1995 | Substantially Equivalent |
| K912901 | TROJAN (TM-TBD) CONDOM | Feb 3, 1992 | Substantially Equivalent |
| K904782 | ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST | Dec 6, 1990 | Substantially Equivalent |
| K904273 | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. | Oct 31, 1990 | Substantially Equivalent |
| K901202 | TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED | Jun 19, 1990 | Substantially Equivalent |
| K901201 | TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED | Apr 16, 1990 | Substantially Equivalent |
| K901198 | TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED | Apr 16, 1990 | Substantially Equivalent |
| K901193 | TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL) | Apr 16, 1990 | Substantially Equivalent |
| K901197 | TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL | Apr 16, 1990 | Substantially Equivalent |