FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOW PREGNANCY TEST KIT
K Number: K921211
·
Decision May 7, 1992
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
14
Review Days
56
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Basic Information
- Device Name
- NOW PREGNANCY TEST KIT
- K Number
- K921211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bio Clinic Co.
- Date Received
- March 12, 1992
- Decision Date
- May 7, 1992
- 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 Bio Clinic Co.
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|---|---|---|---|
| K930791 | AMERICAN POWER CONVERSIONS, BACK-UPS 600 | Aug 6, 1993 | Substantially Equivalent |
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| K926189 | ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE | Jun 24, 1993 | Substantially Equivalent |
| K921958 | ELISA TUBE TSH TEST | Jul 2, 1992 | Substantially Equivalent |
| K922140 | ORTHODERM CONVERTIBLE II | May 27, 1992 | Substantially Equivalent |
| K921212 | MIRCO ELISA HPL TEST KIT | May 7, 1992 | Substantially Equivalent |
| K920920 | ELISA TUBE LH TEST KIT | Apr 8, 1992 | Substantially Equivalent |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Apr 8, 1992 | Substantially Equivalent |
| K920918 | TMB CHROMOGEN/SUBSTRATE REAGENT SET | Apr 7, 1992 | Substantially Equivalent |
| K920917 | ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY | Mar 26, 1992 | Substantially Equivalent |