FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIRST RESPONSE PREGNANCY TEST
K Number: K030258
·
Decision Feb 25, 2003
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
225
Applicant Total
68
Review Days
32
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Basic Information
- Device Name
- FIRST RESPONSE PREGNANCY TEST
- K Number
- K030258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Armkel, LLC
- Date Received
- January 24, 2003
- Decision Date
- February 25, 2003
- 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 Armkel, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | Oct 19, 2004 | Substantially Equivalent |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Dec 16, 2002 | Substantially Equivalent |
| K013433 | TROJAN PASSION BERRY GEL | Mar 5, 2002 | Substantially Equivalent |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |
| K963318 | LEGIONELLA IGG/IGM ELISA TEST SYSTEM | Mar 3, 1997 | Substantially Equivalent |