Anesthesiology
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- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter1Product Code
- MXTDevice, Accessory, Cooling Plate For Tissue Embedding Station1Product Code
- OHZUrine Transport Kit (Excludes Hiv Testing)1Product Code
- OIANeonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)1Product Code
- OIBBlood And Urine Collection Kit (Excludes Hiv Testing)1Product Code
- OIEUrine Collection Kit (Excludes Hiv Testing)1Product Code
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
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Device, Accessory, Cooling Plate For Tissue Embedding Station
- Page Type
- Product Code
- Regulation Medical Specialty
- Pathology
- Review Panel
- Chemistry
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 864.3010
- GMP Exempt?
- Yes
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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CFR § 864.3010 Tissue processing equipment
§ 864.3010 Tissue processing equipment.
(a) Identification. Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.
(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. The devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[45 FR 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]