Hemastaph
FDA 510(k) K840553 · Remel Co.
510(k) numberK840553
Submission
- Device name
- Hemastaph
- Applicant
- Remel Co.
Mchenry, IL, US - Received
- February 8, 1984
- Decision date
- April 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTL – Plasma, Coagulase, Human, Horse And Rabbit
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2160
- Specialty
- Microbiology
Other 510(k)s with product code JTL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950706 | Dryslide CoagulaseJTL · Traditional | Difco Laboratories, Inc. | 05/16/1995SE |
| K883333 | Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional | Immuno-Mycologics, Inc. | 08/25/1988SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | Oxoid U.S.A., Inc. | 06/10/1987SE |
| K861312 | Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional | Micro-Bio-Logics | 04/18/1986SE |
| K833988 | Api Staphase IIIJTL · Traditional | Analytical Products, Inc. | 12/22/1983SE |
| K833858 | Coagulase Plasma, Horse & Rabbit EdtaJTL · Traditional | Otisville Biotech, Inc. | 12/08/1983SE |
| K822988 | Coagulase Plasma-Citrated & EdtaJTL · Traditional | American Scientific Products | 11/05/1982SE |
| K820177 | Coagulase PlasmaJTL · Traditional | Quadroma, Inc. | 02/05/1982SE |
| K812602 | Rabbit Coagulase PlasmaJTL · Traditional | Dutchland Laboratories, Inc. | 09/29/1981SE |
| K811982 | Staphase*JTL · Traditional | Analytical Products, Inc. | 07/28/1981SE |
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| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
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Questions and answers
When was Hemastaph cleared by the FDA?
Hemastaph (K840553) received a 510(k) decision of Substantially Equivalent on April 13, 1984, 65 days after the submission was received.
What is the product code of K840553?
The FDA product code is JTL – Plasma, Coagulase, Human, Horse And Rabbit, a Class I (low risk) device regulated under 21 CFR 866.2160.