Ptt-La Test Kit
FDA 510(k) K921684 · American Bioproducts Co.
510(k) numberK921684
Submission
- Device name
- Ptt-La Test Kit
- Applicant
- American Bioproducts Co.
Parsippany, NJ, US - Received
- April 8, 1992
- Decision date
- June 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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Questions and answers
When was Ptt-La Test Kit cleared by the FDA?
Ptt-La Test Kit (K921684) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 62 days after the submission was received.
What is the product code of K921684?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.