FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-STEP LH OVULATION PREDICTION TEST
K Number: K943252
·
Decision Oct 25, 1994
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
20
Review Days
111
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Basic Information
- Device Name
- PRO-STEP LH OVULATION PREDICTION TEST
- K Number
- K943252
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Disease Detection International, Inc.
- Date Received
- July 6, 1994
- Decision Date
- October 25, 1994
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Disease Detection International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925303 | PRO-STEP PT HCG | Jun 15, 1993 | Substantially Equivalent |
| K925125 | PRO-STEP HCG | Jan 13, 1993 | Substantially Equivalent |
| K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT | Jul 19, 1991 | Substantially Equivalent |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | Sep 5, 1990 | Substantially Equivalent |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | Aug 9, 1990 | Substantially Equivalent |
| K895912 | IMMUNOCARD HCG II-S TEST KIT | Dec 1, 1989 | Substantially Equivalent |
| K896109 | IMMUNOCARD STREP A TEST | Nov 29, 1989 | Substantially Equivalent |
| K884247 | MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT | Apr 10, 1989 | Substantially Equivalent |
| K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT | Apr 10, 1989 | Substantially Equivalent |
| K884246 | MODIFIED DDI SEROCARD HERPES IGG TEST KIT | Apr 10, 1989 | Substantially Equivalent |