FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RESPIRALEX LATEX AGGLUTINATION TEST
K Number: K844399
·
Decision Jan 8, 1985
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
104
Applicant Total
28
Review Days
56
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
- RESPIRALEX LATEX AGGLUTINATION TEST
- K Number
- K844399
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Orion Diagnostica, Inc.
- Date Received
- November 13, 1984
- Decision Date
- January 8, 1985
- Product Code
- GTZ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- IM
- 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 Orion Diagnostica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942286 | DIARLEX ROTA-ADENO | Dec 14, 1994 | Substantially Equivalent |
| K914892 | SALIVA-STIM | Sep 2, 1992 | Substantially Equivalent |
| K904655 | PYLORISET | Oct 21, 1991 | Substantially Equivalent |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | Oct 27, 1988 | Substantially Equivalent |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Oct 27, 1988 | Substantially Equivalent |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | Oct 19, 1988 | Substantially Equivalent |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | Oct 19, 1988 | Substantially Equivalent |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Jun 4, 1987 | Substantially Equivalent |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | May 6, 1987 | Substantially Equivalent |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | Sep 16, 1986 | Substantially Equivalent |