FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST RESPONSE 5 MINUTE PREGNANCY TEST
K Number: K874823
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
70
Review Days
133
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Basic Information
- Device Name
- FIRST RESPONSE 5 MINUTE PREGNANCY TEST
- K Number
- K874823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tambrands, Inc.
- Date Received
- November 24, 1987
- Decision Date
- April 5, 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 Tambrands, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962476 | UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR | Aug 13, 1996 | Substantially Equivalent |
| K960341 | TAMPAX TAMPON WITH ADDITIVE JUNIOR,REGULAR,SUPER, AND SUPER PLUS | Apr 17, 1996 | Substantially Equivalent |
| K952344 | SATIN TOUCH DEODORANT TAMPON JUNIOR, REGULAR, SUPER, SUPER PLUS | Jul 28, 1995 | Substantially Equivalent |
| K944834 | UNSCENTED MENSTRUAL TAMPONS | Dec 21, 1994 | Substantially Equivalent |
| K923932 | TAMPAX TAMPONS, SUPER ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K924303 | TAMPAX TAMPON, REGULAR ABSORBENCY | Jul 29, 1993 | Substantially Equivalent |
| K896989 | TAMPAX TAMPON | Dec 22, 1989 | Substantially Equivalent |
| K896115 | TAMPON, PETAL SOFT PLASTIC APPLI., DEODORANT SUPER | Dec 13, 1989 | Substantially Equivalent |
| K896112 | TAMPAX TAMPON, FLUSHABLE APPLICATOR, SUPER PLUS | Dec 13, 1989 | Substantially Equivalent |
| K896113 | TAMPON, PETAL SOFT PLASTIC APPLICATOR, SUPER PLUS | Dec 13, 1989 | Substantially Equivalent |