510(k) K971503
K971503 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "MYCOPLASMA IGM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 20, 1997. The device falls under product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.), a Class I device regulated under 21 CFR 866.3375. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1997
- Date Received
- April 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- Device Class
- Class I
- Regulation Number
- 866.3375
- Review Panel
- MI
- Submission Type