Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)
FDA 510(k) K971600 · Behring Diagnostics, Inc.
510(k) numberK971600
Submission
- Device name
- Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)
- Applicant
- Behring Diagnostics, Inc.
San Jose, CA, US - Received
- May 1, 1997
- Decision date
- June 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K101752 | Thermo Scientific Cedia Multi-Drug Oft CalibratorsDKB · Traditional | Microgenics Corp. | 04/08/2011SE |
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| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771DKB · Abbreviated | Siemens Healthcare Diagnostics | 06/01/2009SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | Dade Behring, Inc. | 09/14/2006SE |
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Questions and answers
When was Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High) cleared by the FDA?
Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High) (K971600) received a 510(k) decision of Substantially Equivalent on June 25, 1997, 55 days after the submission was received.
What is the product code of K971600?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.