Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor
FDA 510(k) K951331 · Boehringer Mannheim Corp.
510(k) numberK951331
Submission
- Device name
- Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- March 24, 1995
- Decision date
- August 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KHP – Acid, Lactic, Enzymatic Method
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1450
- Specialty
- Clinical Chemistry
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| K982071 | I-Stat Lactate TestKHP · Traditional | I-Stat Corp. | 06/29/1998SE |
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Questions and answers
When was Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor cleared by the FDA?
Accusport Lactate Monitoring System Lactate Test Strips Accusport Monitor (K951331) received a 510(k) decision of Substantially Equivalent on August 11, 1995, 140 days after the submission was received.
What is the product code of K951331?
The FDA product code is KHP – Acid, Lactic, Enzymatic Method, a Class I (low risk) device regulated under 21 CFR 862.1450.