Hema-Tek II Slide Stainer
FDA 510(k) K771559 · Miles Laboratories, Inc.
510(k) numberK771559
Submission
- Device name
- Hema-Tek II Slide Stainer
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- August 15, 1977
- Decision date
- August 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | Fisher Scientific Co., LLC | 09/14/1987SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
More from Shaban Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Hema-Tek II Slide Stainer cleared by the FDA?
Hema-Tek II Slide Stainer (K771559) received a 510(k) decision of Substantially Equivalent on August 25, 1977, 10 days after the submission was received.
What is the product code of K771559?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.