FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DRI-DYE CHECK STRIPS (TM)-405
K Number: K892656
·
Decision May 22, 1989
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
18
Review Days
39
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
- DRI-DYE CHECK STRIPS (TM)-405
- K Number
- K892656
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Awareness Technology, Inc.
- Date Received
- April 13, 1989
- Decision Date
- May 22, 1989
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJX), ordered by most recent decision date.
Beta-CrossLaps CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elecsys CYFRA 21-1 CalCheck 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Multichem A1c
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity DROP LQ Blood Glucose
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON CMV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LIAISON EBV IgM Serum Control Set
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Awareness Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) | Feb 27, 2018 | Substantially Equivalent |
| K013420 | CHEMWELL, ALSO KNOWN AS PROJECT 2900 | Jul 19, 2002 | Substantially Equivalent |
| K010877 | CHEMWELL, MODEL 2900 | May 23, 2001 | Substantially Equivalent |
| K974762 | STAT TRACKS | Jan 28, 1998 | Substantially Equivalent |
| K943729 | DYE CHECK STRIPS 545-630 | Dec 29, 1994 | Substantially Equivalent |
| K941394 | STAT FAX 2600 | Jun 3, 1994 | Substantially Equivalent |
| K923598 | REDI-CHECK PHOTMETER Q.A. | Oct 14, 1992 | Substantially Equivalent |
| K900224 | STAT FAX(TM)-2100 | Mar 1, 1990 | Substantially Equivalent |
| K882938 | STAT FAX(TM) | Sep 9, 1988 | Substantially Equivalent |
| K873451 | PROJECT 300 MICROASSAY BP-12, EIA MINILAB | Nov 4, 1987 | Substantially Equivalent |