FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
K Number: K894389
·
Decision Oct 12, 1989
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
41
Review Days
87
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Basic Information
- Device Name
- CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
- K Number
- K894389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6160
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- July 17, 1989
- Decision Date
- October 12, 1989
- Product Code
- GGX
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GGX | Pipette, Sahli | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGX), ordered by most recent decision date.
View allOther Clearances by Catachem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Sep 8, 1993 | Substantially Equivalent |
| K903341 | MAGNESIUM | Aug 22, 1990 | Substantially Equivalent |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | Jul 31, 1990 | Substantially Equivalent |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Jul 27, 1990 | Substantially Equivalent |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | Dec 21, 1989 | Substantially Equivalent |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Dec 5, 1989 | Substantially Equivalent |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | Nov 8, 1989 | Substantially Equivalent |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | Oct 12, 1989 | Substantially Equivalent |