FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
K Number: K952873
·
Decision Sep 8, 1995
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
39
Review Days
94
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
- K Number
- K952873
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medix Biotech, Inc.
- Date Received
- June 6, 1995
- Decision Date
- September 8, 1995
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTZ | Antisera, All Groups, Streptococcus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTZ), ordered by most recent decision date.
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST
FDA 510(k)
FDA Class 1
·Microbiology
UNI-GOLD STREP A TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
FDA 510(k)
FDA Class 1
·Microbiology
BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI
FDA 510(k)
FDA Class 1
·Microbiology
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
FDA 510(k)
FDA Class 1
·Microbiology
STREP A OIA MAX
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Medix Biotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K924259 | MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 | Nov 25, 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 |