Fitc Labeled Chlamydiae Monoclonal Antibody
FDA 510(k) K844105 · Bartels Immunodiagnostic Supplies, Inc.
510(k) numberK844105
Submission
- Device name
- Fitc Labeled Chlamydiae Monoclonal Antibody
- Applicant
- Bartels Immunodiagnostic Supplies, Inc.
Bellevue, WA, US - Received
- October 23, 1984
- Decision date
- December 6, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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Questions and answers
When was Fitc Labeled Chlamydiae Monoclonal Antibody cleared by the FDA?
Fitc Labeled Chlamydiae Monoclonal Antibody (K844105) received a 510(k) decision of Substantially Equivalent on December 6, 1984, 44 days after the submission was received.