FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K Number: K904725
·
Decision Jan 14, 1991
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
66
Applicant Total
58
Review Days
89
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
- CHLAMYDIA SYSTEM SOFTWARE (CSS)
- K Number
- K904725
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3120
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Date Received
- October 17, 1990
- Decision Date
- January 14, 1991
- Product Code
- LJC
- 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 |
|---|---|---|---|
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJC), ordered by most recent decision date.
CT OIA
FDA 510(k)
FDA Class 1
·Microbiology
IDEIA PCE CHLAMYDIA
FDA 510(k)
FDA Class 1
·Microbiology
CHLAMYDIA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
FDA 510(k)
FDA Class 1
·Microbiology
CHLAMYDIA IGG ELISA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ACCESS CHLAMYDIA ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Kallestad Diag, A Div. of Erbamont, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K910885 | QM300 CALIBRATOR G PACK | Jun 17, 1991 | Substantially Equivalent |
| K910887 | QM300 CONTROL G PACK | Jun 17, 1991 | Substantially Equivalent |
| K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK | Jun 17, 1991 | Substantially Equivalent |
| K902253 | PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT | Jul 26, 1990 | Substantially Equivalent |
| K902462 | MODIFIED QM300 RHEUMATOID FACTOR TEST | Jun 21, 1990 | Substantially Equivalent |
| K900010 | NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR | Apr 3, 1990 | Substantially Equivalent |
| K900009 | NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET | Mar 29, 1990 | Substantially Equivalent |
| K897072 | NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR | Mar 29, 1990 | Substantially Equivalent |
| K894947 | PLATELIA TOXO IGG KIT | Mar 23, 1990 | Substantially Equivalent |
| K894948 | PLATELIA TOXO IGM KIT | Mar 15, 1990 | Substantially Equivalent |