FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K Number: K924259
·
Decision Nov 25, 1992
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
39
Review Days
93
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Basic Information
- Device Name
- MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
- K Number
- K924259
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medix Biotech, Inc.
- Date Received
- August 24, 1992
- Decision Date
- November 25, 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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TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
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Other Clearances by Medix Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) | Sep 8, 1995 | Substantially Equivalent |
| K952319 | CONTRAST & RAPID HCG URINE/SERUM TST | Jun 20, 1995 | Substantially Equivalent |
| K932482 | MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 | Jul 18, 1994 | Substantially Equivalent |
| K932758 | MEDIX BIOTECH BESTEST HCG-URINE TEST KIT | Sep 28, 1993 | Substantially Equivalent |
| K925436 | MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT | Dec 28, 1992 | Substantially Equivalent |
| K922047 | IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 | Aug 5, 1992 | Substantially Equivalent |
| K921700 | TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 | Jun 29, 1992 | Substantially Equivalent |
| K920712 | MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT | Mar 27, 1992 | Substantially Equivalent |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | Mar 18, 1992 | Substantially Equivalent |
| K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT | Mar 4, 1992 | Substantially Equivalent |