FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEK-STIX CONTROL STRIPS FOR URINALYSIS
K Number: K931467
·
Decision May 11, 1993
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
60
Applicant Total
145
Review Days
48
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Basic Information
- Device Name
- CHEK-STIX CONTROL STRIPS FOR URINALYSIS
- K Number
- K931467
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- March 24, 1993
- Decision Date
- May 11, 1993
- Product Code
- JJW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JJW | Urinalysis Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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Other Clearances by Heraeus Kulzer, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091494 | FLEXITIME FLOW | Jul 31, 2009 | Substantially Equivalent |
| K063062 | HKBOND 2006 | Dec 1, 2006 | Substantially Equivalent |
| K060994 | MONDIAL | May 22, 2006 | Substantially Equivalent |
| K052543 | HERACERAM ZIRKONIA | Oct 25, 2005 | Substantially Equivalent |
| K043504 | PALAIMPACT | Jan 28, 2005 | Substantially Equivalent |
| K043295 | VERSYO.DIRECT | Jan 5, 2005 | Substantially Equivalent |
| K042878 | FLEXITIME XTREME | Dec 17, 2004 | Substantially Equivalent |
| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
| K040859 | HERACERAM PRESS | May 20, 2004 | Substantially Equivalent |
| K040043 | NDX-40 ALLOY | Mar 3, 2004 | Substantially Equivalent |