510(k) K922233
- Device
- Olympus Calcium Reagent
- Applicant
- OLYMPUS CORP.
- 510(k) number
- K922233
- Product code
- CIC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-07-10
- Date received
- 1992-05-12
- Regulation
- 862.1145
- Classification name
- Cresolphthalein Complexone, Calcium
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAURA STORMS-TYLER
- Address
- 4 Nevada Dr. Lake Success NY US 11042 11042
FDA Registration Numbers#
- 3013660430
- 3006198300
- 3003795116
- 1181121
- 2432235
- 9610529
- 1832216
- 8040374
- 1181055
- 2517506
- 1827821
- 3004493545
- 3010825766
- 3000148879
- 2085064
- 1616487
- 9610126
- 3021841051
- 3003593973
Source Documents#
510(k) summary PDF not indicated by FDA
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