FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SYNERMED CALCIUM REAGENT KIT
K Number: K903233
·
Decision Oct 4, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
98
Applicant Total
45
Review Days
73
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
- SYNERMED CALCIUM REAGENT KIT
- K Number
- K903233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Synermed, Inc.
- Date Received
- July 23, 1990
- Decision Date
- October 4, 1990
- Product Code
- CIC
- 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 |
|---|---|---|---|
| CIC | Cresolphthalein Complexone, Calcium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CIC), ordered by most recent decision date.
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Synermed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973109 | SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT | Sep 25, 1997 | Substantially Equivalent |
| K972716 | SYNERMED TOTAL BILIRUBIN REAGENT KIT | Aug 7, 1997 | Substantially Equivalent |
| K971491 | SYNERMED IR 200 CHEMISTRY ANALYZER | Jun 26, 1997 | Substantially Equivalent |
| K962479 | SYNERMED ISE REAGENTS | Mar 3, 1997 | Substantially Equivalent |
| K963939 | SYNERMED DIRECT BILIRUBIN REAGENT KIT | Dec 18, 1996 | Substantially Equivalent |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Mar 11, 1996 | Substantially Equivalent |
| K953395 | SYNERMED CALCIUM REAGENT KIT | Aug 31, 1995 | Substantially Equivalent |
| K952179 | SYNERMED ISE REAGENTS | Jun 20, 1995 | Substantially Equivalent |
| K943924 | CREATININE-PO REAGENT KIT | Sep 20, 1994 | Substantially Equivalent |
| K941091 | SYNERMED AMYLASE REAGENT KIT | May 3, 1994 | Substantially Equivalent |