Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752
FDA 510(k) K990888 · Bio-Rad
510(k) numberK990888
Submission
- Device name
- Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- March 10, 1999
- Decision date
- April 7, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752 cleared by the FDA?
Modification to Liquichek Spinal Fluid Control, Item Nos. 751, 752 (K990888) received a 510(k) decision of Substantially Equivalent on April 7, 1999, 28 days after the submission was received.
What is the product code of K990888?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.