FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
K Number: K925880
·
Decision Feb 5, 1993
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
238
Review Days
78
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
- KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
- K Number
- K925880
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eastman Kodak Company
- Date Received
- November 19, 1992
- Decision Date
- February 5, 1993
- 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 Eastman Kodak Company
| K Number | Device Name | ||
|---|---|---|---|
| K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 | Mar 31, 2006 | Substantially Equivalent |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | Mar 16, 2006 | Substantially Equivalent |
| K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM | Feb 8, 2006 | Substantially Equivalent |
| K060055 | KODAK PACS | Feb 7, 2006 | Substantially Equivalent |
| K053347 | KODAK CARESTREAM PACS | Jan 4, 2006 | Substantially Equivalent |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | Jun 21, 2005 | Substantially Equivalent |
| K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 | Jun 1, 2005 | Substantially Equivalent |
| K042159 | KODAK COLOR MEDICAL IMAGER 1000 | Sep 24, 2004 | Substantially Equivalent |
| K042158 | KODAK MEDICAL IMAGER 300 | Sep 24, 2004 | Substantially Equivalent |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | May 24, 2004 | Substantially Equivalent |