Chrom Z Chromogenic Assays
FDA 510(k) K951943 · Helena Laboratories
510(k) numberK951943
Submission
- Device name
- Chrom Z Chromogenic Assays
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 26, 1995
- Decision date
- November 13, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JBQ – Antithrombin Iii Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7060
- Specialty
- Hematology
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| K022195 | Coamatic AT-400JBQ · Traditional | Instrumentation Laboratory CO | 08/07/2002SE |
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Questions and answers
When was Chrom Z Chromogenic Assays cleared by the FDA?
Chrom Z Chromogenic Assays (K951943) received a 510(k) decision of Substantially Equivalent on November 13, 1995, 201 days after the submission was received.
What is the product code of K951943?
The FDA product code is JBQ – Antithrombin Iii Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7060.